Length of StayNCT02687412
Fast-track Surgery After Gynecological Oncology Surgery
A study testing pre-operative assessment, counseling and education, Preoperative nutritional drink up to 4 h prior to surgery and bowel preparation in people with Length of Stay and Postoperative Complications, run by Ling Cui at 1 site in China.
Trial summary
Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Length of Stay, Postoperative Complications, CRP
- What is being tested?
- pre-operative assessment, counseling and education, Preoperative nutritional drink up to 4 h prior to surgery and bowel preparation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2016to 21 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
- Aged 18 years or older
- Signed informed consent provided
Who cannot join
- Patients with a documented infection at the time of operation
- Aged 71 years or older
- Patients with ileus at the time of operation
- Patients with hypocoagulability
- Patients with psychosis, Alcohol dependence or drug abuse history
- Patients with primary nephrotic or hepatic disease
- Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure>90mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fast-track Surgery After Gynaecological Oncological Surgery
Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.
The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.
The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.
Read the detailed description
Methods/Design
Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.
The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.
- Conditions
- Length of Stay, Postoperative Complications, CRP
- Being tested
- pre-operative assessment, counseling and education, Preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, preoperative treatment with carbohydrates, fast solid
- Keywords
- Fast-track surgery, Gynecological oncology, Hospitalization post-operation, Complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative assessment, counseling and educationProcedure or surgery
pre-operative assessment, counseling and FT management education
Preoperative nutritional drink up to 4 h prior to surgeryProcedure or surgery
Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used
bowel preparationProcedure or surgery
patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool
preoperative treatment with carbohydratesProcedure or surgery
preoperative treatment with carbohydrates (patients without diabetes).
fast solidProcedure or surgery
fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;
avoiding hypothermiaProcedure or surgery
avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.
Postoperative glycaemic controlProcedure or surgery
Postoperative glycaemic control;
postoperative nausea and vomiting (PONV) control;Procedure or surgery
early postoperative dietProcedure or surgery
early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).
pre-operative fasting at least 8hProcedure or surgery
bowel preparation for traditional surgeryProcedure or surgery
Oral bowel preparations or mechanical bowl until liquid stool
began to take solid diet after anal exhaustProcedure or surgery
6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust
| Study group | Role | What they receive |
|---|---|---|
| Fast-track Surgery | Experimental | Pre-operative: Assessment, counseling and education; preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, only oral intestinal cleaner，antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia keeping temperature at 36 ±0.5℃, antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery). Receives: Procedure: pre-operative assessment, counseling and education; Procedure: Preoperative nutritional drink up to 4 h prior to surgery; Procedure: bowel preparation; Procedure: preoperative treatment with carbohydrates; Procedure: fast solid; Procedure: avoiding hypothermia; Procedure: Postoperative glycaemic control; Procedure: postoperative nausea and vomiting (PONV) control;; Procedure: early postoperative diet |
| Traditional surgery | Other | pre-operative assessment：pre-operative fasting at least 8h, bowel preparation for traditional surgery, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.
Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust Receives: Procedure: pre-operative fasting at least 8h; Procedure: bowel preparation for traditional surgery; Procedure: began to take solid diet after anal exhaust |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization Post-operation
days from operation date to discharge date
Measured: up to 12 months
The Total Cost (RMB)
The total cost from hospitalization
Measured: 12 month
Secondary outcomes (9)
CRP
C-Reactive protein mg/L
Measured: up to 12 months
Number of Participants With Complications
Count of patients with complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis.
Measured: up to 12 months
Number of Participants With Infection,
infection(wound infection, lung infection, intraperitoneal infection, operation space infection)
Measured: up to 12 months
Number of Participants With Postoperative Nausea and Vomiting (PONV)
it was recognized that nausea and vomiting are common side effects of surgical recovery
Measured: up to 12 months
Number of Participants With Ileus
is a disruption of the normal propulsive ability of the gastrointestinal tract
Measured: up to 12 months
Number of Participants With Postoperative Haemorrhage
Evidence of blood loss from drains or based on ultrasonography
Measured: up to 12 months
Number of Participants With Postoperative Thrombosis
Evidence of blood thrombosis of participants after surgery
Measured: up to 12 months
PCT Calcitonin Postoperative
value of calcitonin postoperative
Measured: 12 month
Cost of Surgical Therapy
Cost of surgical therapy (RMB)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start21 Nov 2016
- Primary completion2 Sep 2017
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Length of StayStudies of the same condition, open and under way.
- 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
- Model description
- prospective randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ling Cui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ling Cui, Sichuan Cancer Hospital and Research Institute
- Investigators
- Ling Cui, MD, Study chair, Sichuan Cancer Hospital and Research InstituteYu Shi, Principal investigator, Sichuan Cancer Hospital and Research InstituteHong Liu, Principal investigator, Sichuan Cancer Hospital and Research InstituteDengfeng Wang, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687412
- Sponsor's protocol ID
- SichuanCHRI
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2016
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kehlet H. Fast-track colorectal surgery. Lancet. 2008 Mar 8;371(9615):791-3. doi: 10.1016/S0140-6736(08)60357-8. No abstract available.
PubMed 18328911Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
PubMed 12095591Polle SW, Wind J, Fuhring JW, Hofland J, Gouma DJ, Bemelman WA. Implementation of a fast-track perioperative care program: what are the difficulties? Dig Surg. 2007;24(6):441-9. doi: 10.1159/000108327. Epub 2007 Sep 13.
PubMed 17851238Acheson N, Crawford R. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):271-3. doi: 10.1111/j.1471-0528.2010.02811.x. No abstract available.
PubMed 21226823Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.
PubMed 7891489Carter J, Szabo R, Sim WW, Pather S, Philp S, Nattress K, Cotterell S, Patel P, Dalrymple C. Fast track surgery: a clinical audit. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):159-63. doi: 10.1111/j.1479-828X.2009.01134.x.
PubMed 20522073Bona S, Molteni M, Rosati R, Elmore U, Bagnoli P, Monzani R, Caravaca M, Montorsi M. Introducing an enhanced recovery after surgery program in colorectal surgery: a single center experience. World J Gastroenterol. 2014 Dec 14;20(46):17578-87. doi: 10.3748/wjg.v20.i46.17578.
PubMed 25516673Carter J. Fast-track surgery in gynaecology and gynaecologic oncology: a review of a rolling clinical audit. ISRN Surg. 2012;2012:368014. doi: 10.5402/2012/368014. Epub 2012 Dec 24.
PubMed 23320193Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
PubMed 15896435Kehlet H. Multimodal approach to postoperative recovery. Curr Opin Crit Care. 2009 Aug;15(4):355-8. doi: 10.1097/MCC.0b013e32832fbbe7.
PubMed 19617822Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.
PubMed 21468643Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
PubMed 18650627Kranke P, Redel A, Schuster F, Muellenbach R, Eberhart LH. Pharmacological interventions and concepts of fast-track perioperative medical care for enhanced recovery programs. Expert Opin Pharmacother. 2008 Jun;9(9):1541-64. doi: 10.1517/14656566.9.9.1541.
PubMed 18518784Lin YS. Preliminary results of laparoscopic modified radical hysterectomy in early invasive cervical cancer. J Am Assoc Gynecol Laparosc. 2003 Feb;10(1):80-4. doi: 10.1016/s1074-3804(05)60239-3.
PubMed 12554999Lu D, Wang X, Shi G. Perioperative enhanced recovery programmes for gynaecological cancer patients. Cochrane Database Syst Rev. 2015 Mar 19;2015(3):CD008239. doi: 10.1002/14651858.CD008239.pub4.
PubMed 25789452
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Surgery After Gynaecological Oncological Surgery
- ClinicalTrials.gov ID
- NCT02687412
- Acronym / sponsor ID
- SichuanCHRI
- Conditions
- Length of Stay, Postoperative Complications, CRP
- Keywords
- Fast-track surgery, Gynecological oncology, Hospitalization post-operation, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ling CuiUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 2 Sep 2017 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Posted 26 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.
The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.
The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.
Detailed description
Methods/Design
Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.
The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fast-track Surgery | Experimental | Procedure: pre-operative assessment, counseling and education, Procedure: Preoperative nutritional drink up to 4 h prior to surgery, Procedure: bowel preparation, Procedure: preoperative treatment with carbohydrates, Procedure: fast solid, Procedure: avoiding hypothermia, Procedure: Postoperative glycaemic control, Procedure: postoperative nausea and vomiting (PONV) control;, Procedure: early postoperative dietPre-operative: Assessment, counseling and education; preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, only oral intestinal cleaner，antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia keeping temperature at 36 ±0.5℃, antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery). |
| Traditional surgery | Other | Procedure: pre-operative fasting at least 8h, Procedure: bowel preparation for traditional surgery, Procedure: began to take solid diet after anal exhaustpre-operative assessment：pre-operative fasting at least 8h, bowel preparation for traditional surgery, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade. Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
- Aged 18 years or older
- Signed informed consent provided
Key exclusion criteria (7 listed)
- Patients with a documented infection at the time of operation
- Aged 71 years or older
- Patients with ileus at the time of operation
- Patients with hypocoagulability
- Patients with psychosis, Alcohol dependence or drug abuse history
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 |
|---|---|---|
| pre-operative assessment, counseling and educationpre-operative assessment, counseling and FT management education | Procedure or surgery | Fast-track Surgery |
| Preoperative nutritional drink up to 4 h prior to surgeryPreoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used | Procedure or surgery | Fast-track Surgery |
| bowel preparationpatients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool | Procedure or surgery | Fast-track Surgery |
| preoperative treatment with carbohydratespreoperative treatment with carbohydrates (patients without diabetes). | Procedure or surgery | Fast-track Surgery |
| fast solidfast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; | Procedure or surgery | Fast-track Surgery |
| avoiding hypothermiaavoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia. | Procedure or surgery | Fast-track Surgery |
| Postoperative glycaemic controlPostoperative glycaemic control; | Procedure or surgery | Fast-track Surgery |
| postoperative nausea and vomiting (PONV) control; | Procedure or surgery | Fast-track Surgery |
| early postoperative dietearly postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | Procedure or surgery | Fast-track Surgery |
| pre-operative fasting at least 8h | Procedure or surgery | Traditional surgery |
| bowel preparation for traditional surgeryOral bowel preparations or mechanical bowl until liquid stool | Procedure or surgery | Traditional surgery |
| began to take solid diet after anal exhaust6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust | Procedure or surgery | Traditional surgery |
Primary outcome
Length of Hospitalization Post-operation
Time frame: up to 12 months
days from operation date to discharge date
The Total Cost (RMB)
Time frame: 12 month
The total cost from hospitalization
9 secondary outcomes
CRP
Time frame: up to 12 months
Number of Participants With Complications
Time frame: up to 12 months
Number of Participants With Infection,
Time frame: up to 12 months
Number of Participants With Postoperative Nausea and Vomiting (PONV)
Time frame: up to 12 months
Number of Participants With Ileus
Time frame: up to 12 months
Number of Participants With Postoperative Haemorrhage
Time frame: up to 12 months
Number of Participants With Postoperative Thrombosis
Time frame: up to 12 months
PCT Calcitonin Postoperative
Time frame: 12 month
Cost of Surgical Therapy
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18328911Kehlet H. Fast-track colorectal surgery. Lancet. 2008 Mar 8;371(9615):791-3. doi: 10.1016/S0140-6736(08)60357-8. No abstract available.
- Background: PubMed 12095591Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
- Background: PubMed 17851238Polle SW, Wind J, Fuhring JW, Hofland J, Gouma DJ, Bemelman WA. Implementation of a fast-track perioperative care program: what are the difficulties? Dig Surg. 2007;24(6):441-9. doi: 10.1159/000108327. Epub 2007 Sep 13.
- Results publication: PubMed 21226823Acheson N, Crawford R. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):271-3. doi: 10.1111/j.1471-0528.2010.02811.x. No abstract available.
- Results publication: PubMed 7891489Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.
- Results publication: PubMed 20522073Carter J, Szabo R, Sim WW, Pather S, Philp S, Nattress K, Cotterell S, Patel P, Dalrymple C. Fast track surgery: a clinical audit. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):159-63. doi: 10.1111/j.1479-828X.2009.01134.x.
- Results publication: PubMed 25516673Bona S, Molteni M, Rosati R, Elmore U, Bagnoli P, Monzani R, Caravaca M, Montorsi M. Introducing an enhanced recovery after surgery program in colorectal surgery: a single center experience. World J Gastroenterol. 2014 Dec 14;20(46):17578-87. doi: 10.3748/wjg.v20.i46.17578.
- Results publication: PubMed 23320193Carter J. Fast-track surgery in gynaecology and gynaecologic oncology: a review of a rolling clinical audit. ISRN Surg. 2012;2012:368014. doi: 10.5402/2012/368014. Epub 2012 Dec 24.
- Results publication: PubMed 15896435Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
- Results publication: PubMed 19617822Kehlet H. Multimodal approach to postoperative recovery. Curr Opin Crit Care. 2009 Aug;15(4):355-8. doi: 10.1097/MCC.0b013e32832fbbe7.
- Results publication: PubMed 21468643Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.
- Results publication: PubMed 18650627Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
- Individual participant dataSharing planned: No
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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.
Ling Cui, MD study chair
Sichuan Cancer Hospital and Research Institute
Yu Shi principal investigator
Sichuan Cancer Hospital and Research Institute
Hong Liu principal investigator
Sichuan Cancer Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-operative assessment, counseling and education, Preoperative nutritional drink up to 4 h prior to surgery and bowel preparation in people with Length of Stay and Postoperative Complications, run by Ling Cui 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 7 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: finished, as of the sponsor's last update on 26 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospitalization Post-operation (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 NCT02687412, which also lists 24 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 26 Sep 2019.