Laparoscopic Radical GastrectomyNCT04029753
Patients Undergoing Laparoscopic Radical Gastrectomy Walk Out From Operating Room After Surgery ( WOFOR-G-01 )
A study testing Walk out from operating room in people with Laparoscopic Radical Gastrectomy and Enhanced Recovery After Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Although early and progressive mobility is widely accepted as an important aspect of postoperative care, guidelines and recommendations suggesting the exact timing and intensity of mobilization efforts are nonexistent. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Radical Gastrectomy, Enhanced Recovery After Surgery
- What is being tested?
- Walk out from operating room
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2019to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 Years old
- scheduled for laparoscopic radical gastrectomy.
- American Society of Anesthesiologists (ASA) grading I or II
Who cannot join
- Patients have severe cardiac diseases (cardiac function grading greater than grade 3/arrhythmia including sick sinus syndrome, atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature,multiple ventricular premature, ventricular premature R on T, ventricular fibrillation and ventricular flutter/acute coronary syndrome) or respiratory failure or hepatic failure or renal failure;
- Body mass index (BMI) ≥30 kg/m2;
- Preoperative hemoglobin<80 g/L or albumin<30 g/L
- Patients have diabetics or patients with gastric emptying disorders;
- Patients with poor blood pressure control (receive regular antihypertensive medical treatment but still have systolic blood pressure>150 mmHg and/or diastolic blood pressure>90 mmHg );
- Patients have schizophrenia, epilepsy, Parkinson's disease, mental retardation, or hearing impairment.
Show all 12Show fewer
- Patients have thrombosis such as in lower extremity or in vena cava or in other veins.
- Patients have neuromuscular disorders affecting lower limb activity, such as myasthenia gravis and cerebral infarction, which cause lower limb muscle weakness;
- Patients have contraindications for epidural puncture.
- Postoperative placement of drainage tube for coelom hyperthermia perfusion
- Patients participate in other clinical trials.
- Patients refuse to sign informed consent for research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Sanqing Jin, MD, 0086-13719366863, sanqingjin@hotmail.com
Zhinan Zheng, MD, 0086-15915734893, 253039456@qq.com
About this study
Official title: Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Radical Gastrectomy
Although early and progressive mobility is widely accepted as an important aspect of postoperative care, guidelines and recommendations suggesting the exact timing and intensity of mobilization efforts are nonexistent. We propose the concept of walking out from the operating room (WOFOR), which means under meticulous anesthesia treatment, perfect postoperative analgesia conditions, rigorous assessment of consciousness and normal muscle strength, postoperative patients can walk safely out of the operating room and return to the ward. The aim of this randomized controlled trial is to investigate the effect of walking out from the operating room on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy.
Read the detailed description
Postoperative bed rest increases the risk of complications such as thromboembolism and intestinal adhesion, but actual clinical effects of early mobilization still need randomized control trails to prove. The aim of this randomized controlled trial is to investigate the effect of walking out from the operating room (very early mobilization after surgery) on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy.
A sample size of 96 patients in each group is calculated by a prior power analysis on the basis of the following assumptions: (1) an absolute reduction in the length of the hospital stay by 1 day, (2) standard deviations are 2 days in the experimental group and the control group, (3)α=0.05, (4) power 90% and (5) missed follow-up rate 10%. Considering that this study is not for rare diseases, in order to ensure adequate sample size, we adjust the sample size of each group to an integer of 100.
Patients will receive written and verbal information about the trial before written consent is obtained. The randomization will take place when the surgeons confirm preliminarily there is no need to place drainage tube for coelom hyperthermia perfusion after laparoscopy. Then patients will be assigned to either intervention (return to ward by walking) or control group (return to ward by lying on the transporting bed). A stratified randomization with three factors including sex, age and total or distal gastrectomy will be performed to ensure an even spread. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.
The patients will receive general anesthesia combined with epidural analgesia. After surgery, the patients will be evaluated whether fulfilling the criteria for mobilization including stable physiological parameters, consciousness, normal level of orientation and muscle strength, and painlessness every ten minutes. If patients fulfill the criteria, they will receive different methods of returning to the ward based on the grouping. In the control group, the patient will return to the ward by lying on the transporting bed. In the intervention group, the patients will be raised to a sitting position for five minutes. If the patients do not complain any discomfort and have stable physiological parameters, they will be encouraged to stand. If standing do not cause any discomfort, they will be encouraged to walk within the range of 5-meter long and 60-centimeter wide. If patients can walk within the range, they will return to the surgical ward by walking under the protection of medical staffs.
Then, all study patients will be subject to the same management such as the guidance of drink and diet recovery, the guidance of mobilization in the ward, nutrition supplement after surgery, and the criteria of drainage removal and hospital discharge. The outcomes such as the length of hospital stay after surgery will be recorded and analyzed to evaluate the effects of walking out from the operating room. The analysis of Intention-to-treat and Per-protocol-sets will be both performed by statisticians.
- Being tested
- Walk out from operating room
- Keywords
- Early Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk out from operating roomBehavioural
After the surgery of laparoscopic radical gastrectomy, patients will be encouraged to walk out from the operating room and return to the ward by walking under the condition of stable physiological parameters, painlessness, clear consciousness and normal muscle strength of lower limb.
| Study group | Role | What they receive |
|---|---|---|
| Walk out from operating room | Experimental | Patients will return to the ward after surgery by walking. Receives: Behavioral: Walk out from operating room |
| Leave operating room by transporting bed | No intervention | Patients will return to the ward after surgery by lying on the transporting bed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay after surgery
hospital stay time from operation completion to actual hospital discharge
Measured: at hospital discharge(expected 7 days after surgery)
Secondary outcomes (15)
Time to fulfill the criteria of hospital discharge
the ideal time point for discharge, which is also considered as recovery time. The criteria for measuring recovery time included: 1) the patients receive 80% of normal nutritional support （30 kcal/kg/day calories is regard as normal nutritional support）and 30ml/kg fluid intake by oral; 2)gastrointestinal function has been restored: flatus with or without defecation; 3)analgesic-free, which is defined as visual analogue scale ≤3 without intravenous analgesic drugs, 4) adequate mobility without support; 5) afebrile status without major infectious complications
Measured: expected 7 days after surgery
The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.
the percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.
Measured: expected 6 days after surgery
Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40)
to evaluate the postoperative recovery using 40-item quality of recovery scoring system including emotional state (9items), physical comfort (12 items), physical independence (5 items), psychologic support (7 items), and pain (7 items). Each item is graded on a five-point Likert scale, and global scores range from 40 (extremely poor quality of recovery)to 200 (high quality of recovery). Each item is graded on a five-point Likert scale, and global scores range from 40 (extremely poor quality of recovery) to 200 (high quality of recovery).
Measured: every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Six-minute walking test
physical capacity measured with the six-minute Walking test before surgery and after surgery.The longer walking distance in six minutes, the better physical capacity.
Measured: the day before surgery, every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Anxiety score
anxiety state evaluated by State-Trait Anxiety Inventory Form. The form used in this study is the Chinese version. The scales consist of 20 items; the responses range from 1 to 4 points (forced choice). The scores range from 20 (extremely low level of anxiety) to 80 (high level of anxiety). The STAI classifies anxiety into five stages: stages 1 and 2 suggest mild anxiety; stage 3 suggests moderate anxiety, and stages 4 and 5 suggest severe anxiety.
Measured: the day before surgery, every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Postoperative pain score
pain score after surgery is evaluated using a visual analogue scale 0-10 rated by the patients
Measured: every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Severity of postoperative nausea and vomiting
everity of postoperative nausea and vomiting is measured with the PONV intensity grading. Briefly, no PONV is defined as the absence of any emetic symptoms and nausea during the entire study period. Mild PONV is defined as the occurrence of mild nausea or one episode of vomiting if caused by an exogenous stimulus such as drinking or movement. Moderate PONV is reached when the patient vomits up to 2 times or experiences nausea that requires a rescue antiemetic therapy only once. Severe PONV is reached if the patient suffers more than two emetic episodes or needs more than one dose of a rescue antiemetic drugs.
Measured: every 24 hours after surgery (at 1-day, 2-day, 3-day)
Time to first flatus after surgery
the time length between operation completion and the first flatus
Measured: from the time of operation completion until the time of the first flatus occurrence, assessed up to 7 days.
Time to first defecation after surgery
the time length between operation completion and the first defecation
Measured: from the time of operation completion until the time of the first defecation occurrence, assessed up to 10 days.
The volume of drainage after surgery
total volume of drainage after surgery and drainage volume every 24 hours after surgery.
Measured: every 24 hours from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
Time to the removal of drainage tube
recorded the time length between operation completion and the removal of drainage tube
Measured: from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
Incidence of surgical complications within 7 days after surgery
incidence of bleeding, wound infection, wound dehiscence, ileus, stenosis, Leakage within 30 days after surgery
Measured: 7 days after surgery
Incidence of surgical complications within 30 days after surgery
incidence of bleeding, wound infection, wound dehiscence, ileus, stenosis, Leakage within 30 days after surgery
Measured: 30 days after surgery
Unplanned re-admission incidence within 30 days after operation
incidence of unplanned admit to hospital again within 30 days after operation
Measured: 30 days after operation
Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation
incidence of a complex event consisting of all-cause death, myocardial infarction, stroke and emergency target vessel revascularization within 30 days after surgery
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start27 Aug 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Radical GastrectomyStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Sanqing Jin, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029753
- Sponsor's protocol ID
- 2019ZSLYEC-053
- Status last verified
- Oct 2022
- First submitted
- 14 Jul 2019
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ding J, Sun B, Song P, Liu S, Chen H, Feng M, Guan W. The application of enhanced recovery after surgery (ERAS)/fast-track surgery in gastrectomy for gastric cancer: a systematic review and meta-analysis. Oncotarget. 2017 Jun 20;8(43):75699-75711. doi: 10.18632/oncotarget.18581. eCollection 2017 Sep 26.
PubMed 29088903Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.
PubMed 25047143Pedziwiatr M, Mavrikis J, Witowski J, Adamos A, Major P, Nowakowski M, Budzynski A. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018 May 9;35(6):95. doi: 10.1007/s12032-018-1153-0.
PubMed 29744679Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
PubMed 27875094Chen Hu J, Xin Jiang L, Cai L, Tao Zheng H, Yuan Hu S, Bing Chen H, Chang Wu G, Fei Zhang Y, Chuan Lv Z. Preliminary experience of fast-track surgery combined with laparoscopy-assisted radical distal gastrectomy for gastric cancer. J Gastrointest Surg. 2012 Oct;16(10):1830-9. doi: 10.1007/s11605-012-1969-4. Epub 2012 Aug 2.
PubMed 22854954Li MZ, Wu WH, Li L, Zhou XF, Zhu HL, Li JF, He YL. Is ERAS effective and safe in laparoscopic gastrectomy for gastric carcinoma? A meta-analysis. World J Surg Oncol. 2018 Jan 26;16(1):17. doi: 10.1186/s12957-018-1309-6.
PubMed 29373978Ma Z, Bao X, Gu J. Effects of laparoscopic radical gastrectomy and the influence on immune function and inflammatory factors. Exp Ther Med. 2016 Aug;12(2):983-986. doi: 10.3892/etm.2016.3404. Epub 2016 May 27.
PubMed 27446308Abdikarim I, Cao XY, Li SZ, Zhao YQ, Taupyk Y, Wang Q. Enhanced recovery after surgery with laparoscopic radical gastrectomy for stomach carcinomas. World J Gastroenterol. 2015 Dec 21;21(47):13339-44. doi: 10.3748/wjg.v21.i47.13339.
PubMed 26715818Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e.
PubMed 21160309van der Leeden M, Huijsmans R, Geleijn E, de Lange-de Klerk ES, Dekker J, Bonjer HJ, van der Peet DL. Early enforced mobilisation following surgery for gastrointestinal cancer: feasibility and outcomes. Physiotherapy. 2016 Mar;102(1):103-10. doi: 10.1016/j.physio.2015.03.3722. Epub 2015 May 7.
PubMed 26059985Havey R, Herriman E, O'Brien D. Guarding the gut: early mobility after abdominal surgery. Crit Care Nurs Q. 2013 Jan-Mar;36(1):63-72. doi: 10.1097/CNQ.0b013e3182753237.
PubMed 23221443
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Walking Out From Operating Room on Postoperative Recovery of Patients Undergoing Laparoscopic Radical Gastrectomy
- ClinicalTrials.gov ID
- NCT04029753
- Acronym / sponsor ID
- 2019ZSLYEC-053
- Keywords
- Early Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although early and progressive mobility is widely accepted as an important aspect of postoperative care, guidelines and recommendations suggesting the exact timing and intensity of mobilization efforts are nonexistent. We propose the concept of walking out from the operating room (WOFOR), which means under meticulous anesthesia treatment, perfect postoperative analgesia conditions, rigorous assessment of consciousness and normal muscle strength, postoperative patients can walk safely out of the operating room and return to the ward. The aim of this randomized controlled trial is to investigate the effect of walking out from the operating room on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy.
Detailed description
Postoperative bed rest increases the risk of complications such as thromboembolism and intestinal adhesion, but actual clinical effects of early mobilization still need randomized control trails to prove. The aim of this randomized controlled trial is to investigate the effect of walking out from the operating room (very early mobilization after surgery) on the postoperative recovery of patients undergoing laparoscopic radical gastrectomy.
A sample size of 96 patients in each group is calculated by a prior power analysis on the basis of the following assumptions: (1) an absolute reduction in the length of the hospital stay by 1 day, (2) standard deviations are 2 days in the experimental group and the control group, (3)α=0.05, (4) power 90% and (5) missed follow-up rate 10%. Considering that this study is not for rare diseases, in order to ensure adequate sample size, we adjust the sample size of each group to an integer of 100.
Patients will receive written and verbal information about the trial before written consent is obtained. The randomization will take place when the surgeons confirm preliminarily there is no need to place drainage tube for coelom hyperthermia perfusion after laparoscopy. Then patients will be assigned to either intervention (return to ward by walking) or control group (return to ward by lying on the transporting bed). A stratified randomization with three factors including sex, age and total or distal gastrectomy will be performed to ensure an even spread. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.
The patients will receive general anesthesia combined with epidural analgesia. After surgery, the patients will be evaluated whether fulfilling the criteria for mobilization including stable physiological parameters, consciousness, normal level of orientation and muscle strength, and painlessness every ten minutes. If patients fulfill the criteria, they will receive different methods of returning to the ward based on the grouping. In the control group, the patient will return to the ward by lying on the transporting bed. In the intervention group, the patients will be raised to a sitting position for five minutes. If the patients do not complain any discomfort and have stable physiological parameters, they will be encouraged to stand. If standing do not cause any discomfort, they will be encouraged to walk within the range of 5-meter long and 60-centimeter wide. If patients can walk within the range, they will return to the surgical ward by walking under the protection of medical staffs.
Then, all study patients will be subject to the same management such as the guidance of drink and diet recovery, the guidance of mobilization in the ward, nutrition supplement after surgery, and the criteria of drainage removal and hospital discharge. The outcomes such as the length of hospital stay after surgery will be recorded and analyzed to evaluate the effects of walking out from the operating room. The analysis of Intention-to-treat and Per-protocol-sets will be both performed by statisticians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk out from operating room | Experimental | Behavioral: Walk out from operating roomPatients will return to the ward after surgery by walking. |
| Leave operating room by transporting bed | No intervention | –Patients will return to the ward after surgery by lying on the transporting bed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 Years old
- scheduled for laparoscopic radical gastrectomy.
- American Society of Anesthesiologists (ASA) grading I or II
Key exclusion criteria (12 listed)
- Patients have severe cardiac diseases (cardiac function grading greater than grade 3/arrhythmia including sick sinus syndrome, atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature,multiple ventricular premature, ventricular premature R on T, ventricular fibrillation and ventricular flutter/acute coronary syndrome) or respiratory failure or hepatic failure or renal failure;
- Body mass index (BMI) ≥30 kg/m2;
- Preoperative hemoglobin<80 g/L or albumin<30 g/L
- Patients have diabetics or patients with gastric emptying disorders;
- Patients with poor blood pressure control (receive regular antihypertensive medical treatment but still have systolic blood pressure>150 mmHg and/or diastolic blood pressure>90 mmHg );
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk out from operating roomAfter the surgery of laparoscopic radical gastrectomy, patients will be encouraged to walk out from the operating room and return to the ward by walking under the condition of stable physiological parameters, painlessness, clear consciousness and normal muscle strength of lower limb. | Behavioural | Walk out from operating room |
Primary outcome
Length of hospital stay after surgery
Time frame: at hospital discharge(expected 7 days after surgery)
hospital stay time from operation completion to actual hospital discharge
15 secondary outcomes
Time to fulfill the criteria of hospital discharge
Time frame: expected 7 days after surgery
The percentage of patients feeling ready for hospital discharge when they reach the discharge criteria.
Time frame: expected 6 days after surgery
Postoperative recovery score using 40-item quality of recovery scoring system(QoR-40)
Time frame: every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Six-minute walking test
Time frame: the day before surgery, every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Anxiety score
Time frame: the day before surgery, every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Postoperative pain score
Time frame: every 24 hours after surgery (at 1-day, 2-day, 3-day), and then every 48 hours until the discharge after surgery (at 5-day, 7-day (if any), 9-day (if any)...)
Severity of postoperative nausea and vomiting
Time frame: every 24 hours after surgery (at 1-day, 2-day, 3-day)
Time to first flatus after surgery
Time frame: from the time of operation completion until the time of the first flatus occurrence, assessed up to 7 days.
Time to first defecation after surgery
Time frame: from the time of operation completion until the time of the first defecation occurrence, assessed up to 10 days.
The volume of drainage after surgery
Time frame: every 24 hours from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
Time to the removal of drainage tube
Time frame: from the time of operation completion until the time of drainage tube removal, assessed up to 30 days.
Incidence of surgical complications within 7 days after surgery
Time frame: 7 days after surgery
Incidence of surgical complications within 30 days after surgery
Time frame: 30 days after surgery
Unplanned re-admission incidence within 30 days after operation
Time frame: 30 days after operation
Incidence of major cardiovascular and cerebrovascular adverse events within 30 days after operation
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 29088903Ding J, Sun B, Song P, Liu S, Chen H, Feng M, Guan W. The application of enhanced recovery after surgery (ERAS)/fast-track surgery in gastrectomy for gastric cancer: a systematic review and meta-analysis. Oncotarget. 2017 Jun 20;8(43):75699-75711. doi: 10.18632/oncotarget.18581. eCollection 2017 Sep 26.
- Background: PubMed 25047143Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.
- Background: PubMed 29744679Pedziwiatr M, Mavrikis J, Witowski J, Adamos A, Major P, Nowakowski M, Budzynski A. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018 May 9;35(6):95. doi: 10.1007/s12032-018-1153-0.
- Background: PubMed 27875094Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
- Background: PubMed 22854954Chen Hu J, Xin Jiang L, Cai L, Tao Zheng H, Yuan Hu S, Bing Chen H, Chang Wu G, Fei Zhang Y, Chuan Lv Z. Preliminary experience of fast-track surgery combined with laparoscopy-assisted radical distal gastrectomy for gastric cancer. J Gastrointest Surg. 2012 Oct;16(10):1830-9. doi: 10.1007/s11605-012-1969-4. Epub 2012 Aug 2.
- Background: PubMed 29373978Li MZ, Wu WH, Li L, Zhou XF, Zhu HL, Li JF, He YL. Is ERAS effective and safe in laparoscopic gastrectomy for gastric carcinoma? A meta-analysis. World J Surg Oncol. 2018 Jan 26;16(1):17. doi: 10.1186/s12957-018-1309-6.
- Background: PubMed 27446308Ma Z, Bao X, Gu J. Effects of laparoscopic radical gastrectomy and the influence on immune function and inflammatory factors. Exp Ther Med. 2016 Aug;12(2):983-986. doi: 10.3892/etm.2016.3404. Epub 2016 May 27.
- Background: PubMed 26715818Abdikarim I, Cao XY, Li SZ, Zhao YQ, Taupyk Y, Wang Q. Enhanced recovery after surgery with laparoscopic radical gastrectomy for stomach carcinomas. World J Gastroenterol. 2015 Dec 21;21(47):13339-44. doi: 10.3748/wjg.v21.i47.13339.
- Background: PubMed 21160309Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e.
- Background: PubMed 26059985van der Leeden M, Huijsmans R, Geleijn E, de Lange-de Klerk ES, Dekker J, Bonjer HJ, van der Peet DL. Early enforced mobilisation following surgery for gastrointestinal cancer: feasibility and outcomes. Physiotherapy. 2016 Mar;102(1):103-10. doi: 10.1016/j.physio.2015.03.3722. Epub 2015 May 7.
- Background: PubMed 23221443Havey R, Herriman E, O'Brien D. Guarding the gut: early mobility after abdominal surgery. Crit Care Nurs Q. 2013 Jan-Mar;36(1):63-72. doi: 10.1097/CNQ.0b013e3182753237.
Related trials for Laparoscopic Radical Gastrectomy
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Recruiting
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Gastric Cancer (GC), Stomach Neoplasms
Recruiting
TEAS for Gastrectomy Recovery
Gastric Cancer (GC), Stomach Neoplasms
RecruitingPhase 2
Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy
Gastrectomy, Postoperative Analgesia
Recruiting
External Oblique Intercostal Block Versus Transversus Abdominis Plane Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Radical Gastrectomy
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanqing Jin, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk out from operating room in people with Laparoscopic Radical Gastrectomy and Enhanced Recovery After Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanqing Jin, MD (0086-13719366863, sanqingjin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay after surgery (time frame: at hospital discharge(expected 7 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029753, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.