Early Oral Nutrition After Total GastrectomyNCT03257280
Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)
A study testing Early oral nutrition in people with Early Oral Nutrition After Total Gastrectomy and Gastric Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
This is a prospective randomized controlled clinical trial to clarify the effect of early oral nutrition introduction after total gastrectomy in gastric cancer patients on the length of hospital stay, comparing an experimental group vs control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Oral Nutrition After Total Gastrectomy, Gastric Cancer
- What is being tested?
- Early oral nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2017to Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring radical total gastrectomy for gastric cancer.
- 18 or above years old.
- Acceptance and signing the full informed consent.
Who cannot join
- Patient with poorly controlled diabetes mellitus (glycosylated hemoglobin levels greater than 7%)
- Emergency surgery.
- Total gastrectomy with esophagus-jejunal manual suture.
- Early dehiscence of esophagus-jejunal anastomosis (first 24 hours).
- Reintervention for abdominal complication in the first 24 hours.
- Surgery involving large intestinal or colon resections.
- Proximal resection margin affected requiring a esophagectomy and reconstruction with coloplasty.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Leandre Farran Teixidor
L'Hospitalet de Llobregat, Barcelona, 08026
Leandre Farran Teixidor, PhD, MD, +34-93-335-90-11 ext. 2316, lfarran@bellvitgehospital.cat
Fernando Estremiana Garcia, MD, +34-93-335-90-11 ext. 2316, festremiana@bellvitgehospital.cat
About this study
Official title: Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Gastric Cancer Patients After Total Gastrectomy: A Prospective Randomized Control Trial (DOPGT_2015)
This is a prospective randomized controlled clinical trial to clarify the effect of early oral nutrition introduction after total gastrectomy in gastric cancer patients on the length of hospital stay, comparing an experimental group vs control group.
Read the detailed description
The total gastrectomy is a high complexity surgery that involves a high morbid-mortality. In our center, the postoperative management consisted in 1 week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a progressive oral diet is begin.
In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was introduced in the surgical patients attempting to improve their postoperative course. This new concept includes the preoperative advices related to the surgery, the intensive mobilization after surgery, the early oral diet, and to avoid the routinary use of the nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is still no good evidence to sport these practice.
Based on the reasons exposed before, the investigators design a prospective randomized controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and if no evidence of drainage leakage the participants will be randomized into two groups: one of them with our classical postoperative management, and the other one implements an early oral nutrition protocol, having in considerations its effectiveness, security, and impact on the hospital stay.
- Being tested
- Early oral nutrition
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral nutritionOther
An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Early oral nutrition | Experimental | An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy. Receives: Other: Early oral nutrition |
| control group | No intervention | In our center, the classical postoperative management consisted in one week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a three days progressive oral diet is begin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
Postoperatory hospital stay in days
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Secondary outcomes (13)
Mortality
Postoperative Mortality: Deaths occurring during admission and / or within 30 days after surgery or during surgical admission if it lasts longer than 30 days.
Measured: During the admission, two weeks and one month after surgery
Hospital readmissions
It will be considered the income produced within 30 days after the surgical intervention in which the cause of the admission is attributed to a complication in relation to the surgical intervention.
Measured: Two weeks and one month after surgery
Weight
weight shall be measured in kilograms
Measured: First day of hospital admission, two weeks and one month after surgery
Anastomotic dehiscence
Anastomotic dehiscence: If the intra-abdominal drainage presents a purulent appearance or an amylase determination> 30, suspicion of anastomosis dehiscence will be made; In this situation, a clinical test (intake of methylene blue) radiological test (with oral contrast) or endoscopy will be requested to confirm the diagnosis. Anastomosis dehiscence will be confirmed if any of the following occurs:
- Exit of methylene blue through intra-abdominal drainage
- Contrast leakage in a radiological test performed for sepsis
- Evidence of dehiscence in a fibrogastroscopy
- Evidence of anastomotic dehiscence during a reintervention
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Duodenal stump leak
Intra-abdominal drainage presents a purulent appearance with amylase determination> 30 and a bilirubin value higher than plasmatic bilirubin.
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Paralytic ileus
When three of the following criteria are met.
Oral intolerance after the fourth postoperative day Abdominal distention and tympanism No bowel motions or flatus Compatible abdominal x-ray
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Intra-Abdominal abscesses
- Radiological criteria: Air inside the collection Collection with heterogeneous and irregular pickup or wall pickup Collection with heterogeneous content
- Isolation of one or more microorganisms in culture after percutaneous collection
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Postoperative Hemoperitoneum
Presence of blood in the abdominal cavity after gastrectomy that needs any kind of treatments
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Evisceration
Extrusion of viscera outside the body through a surgical incision
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Superficial Incisional Surgical Site Infection
Superficial Incisional Surgical Site Infection
Infection within 30 days after the operation and only involves skin and subcutaneous tissue of the incision and at least one of the following:
Purulent drainage with or without laboratory confirmation, from the superficial incision.
Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
At least one of the following signs or symptoms of infection: pain or tenderness, localised swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.
Diagnosis of superficial incisional surgical site infection made by a surgeon or attending physician.
Measured: postoperative 1 day to discharge, up to 1 month after surgery
Height
Height shall be measured in meters
Measured: First day of hospital admission, two weeks and one month after surgery
Percentage of weight lost
Percentage of weight lost shall be measured in percentage
Measured: First day of hospital admission, two weeks and one month after surgery
Impedancemetry
The impedanciometry will record:
Phase-angle Na / K ratio Basal metabolism (Kcal) Fat mass percentage Muscle mass percentage Cell mass percentage Extracellular mass percentage
Measured: First day of hospital admission, two weeks and one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start20 Oct 2017
- Primary completionOct 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Early Oral Nutrition After Total GastrectomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandre Farran Teixidor, Hospital Universitari de Bellvitge
- Investigators
- Leandre Farran Teixidor, PhD, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257280
- Sponsor's protocol ID
- DOPGT_2015
- Status last verified
- Feb 2021
- First submitted
- 7 Jul 2017
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez CA, Agudo A. Carcinogenesis, prevention and early detection of gastric cancer: where we are and where we should go. Int J Cancer. 2012 Feb 15;130(4):745-53. doi: 10.1002/ijc.26430. Epub 2011 Oct 20.
PubMed 21918974Allum WH, Blazeby JM, Griffin SM, Cunningham D, Jankowski JA, Wong R; Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, the British Society of Gastroenterology and the British Association of Surgical Oncology. Guidelines for the management of oesophageal and gastric cancer. Gut. 2011 Nov;60(11):1449-72. doi: 10.1136/gut.2010.228254. Epub 2011 Jun 24. No abstract available.
PubMed 21705456Van Cutsem E, Dicato M, Geva R, Arber N, Bang Y, Benson A, Cervantes A, Diaz-Rubio E, Ducreux M, Glynne-Jones R, Grothey A, Haller D, Haustermans K, Kerr D, Nordlinger B, Marshall J, Minsky BD, Kang YK, Labianca R, Lordick F, Ohtsu A, Pavlidis N, Roth A, Rougier P, Schmoll HJ, Sobrero A, Tabernero J, Van de Velde C, Zalcberg J. The diagnosis and management of gastric cancer: expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2010. Ann Oncol. 2011 Jun;22 Suppl 5:v1-9. doi: 10.1093/annonc/mdr284.
PubMed 21633049Viudez-Berral A, Miranda-Murua C, Arias-de-la-Vega F, Hernandez-Garcia I, Artajona-Rosino A, Diaz-de-Liano A, Vera-Garcia R. Current management of gastric cancer. Rev Esp Enferm Dig. 2012 Mar;104(3):134-41. doi: 10.4321/s1130-01082012000300006.
PubMed 22449155Okines A, Verheij M, Allum W, Cunningham D, Cervantes A; ESMO Guidelines Working Group. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v50-4. doi: 10.1093/annonc/mdq164. No abstract available.
PubMed 20555102Wong J, Kelly KJ, Mittra A, Gonen M, Allen P, Fong Y, Coit D. Rt-PCR increases detection of submicroscopic peritoneal metastases in gastric cancer and has prognostic significance. J Gastrointest Surg. 2012 May;16(5):889-96; discussion 896. doi: 10.1007/s11605-012-1845-2. Epub 2012 Feb 24.
PubMed 22362071Takata A, Kurokawa Y, Fujiwara Y, Nakamura Y, Takahashi T, Yamasaki M, Miyata H, Nakajima K, Takiguchi S, Mori M, Doki Y. Prognostic value of CEA and CK20 mRNA in the peritoneal lavage fluid of patients undergoing curative surgery for gastric cancer. World J Surg. 2014 May;38(5):1107-11. doi: 10.1007/s00268-013-2385-y.
PubMed 24305936Washington K. 7th edition of the AJCC cancer staging manual: stomach. Ann Surg Oncol. 2010 Dec;17(12):3077-9. doi: 10.1245/s10434-010-1362-z. No abstract available.
PubMed 20882416Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
PubMed 21573742Feng F, Ji G, Li JP, Li XH, Shi H, Zhao ZW, Wu GS, Liu XN, Zhao QC. Fast-track surgery could improve postoperative recovery in radical total gastrectomy patients. World J Gastroenterol. 2013 Jun 21;19(23):3642-8. doi: 10.3748/wjg.v19.i23.3642.
PubMed 23801867Deguchi Y, Fukagawa T, Morita S, Ohashi M, Saka M, Katai H. Identification of risk factors for esophagojejunal anastomotic leakage after gastric surgery. World J Surg. 2012 Jul;36(7):1617-22. doi: 10.1007/s00268-012-1559-3.
PubMed 22415758Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Piccione F, Amicucci G. Prevention of anastomotic leakage after total gastrectomy with perioperative supplemental oxygen administration: a prospective randomized, double-blind, controlled, single-center trial. Ann Surg Oncol. 2013 May;20(5):1584-90. doi: 10.1245/s10434-012-2714-7. Epub 2012 Oct 26.
PubMed 23099730Kucukay F, Okten RS, Parlak E, Disibeyaz S, Ozogul Y, Bostanci EB, Olcer T. Self-expanding covered metallic stent treatment of esophagojejunostomy fistulas. Abdom Imaging. 2013 Apr;38(2):244-8. doi: 10.1007/s00261-012-9895-1.
PubMed 22527158Lang H, Piso P, Stukenborg C, Raab R, Jahne J. Management and results of proximal anastomotic leaks in a series of 1114 total gastrectomies for gastric carcinoma. Eur J Surg Oncol. 2000 Mar;26(2):168-71. doi: 10.1053/ejso.1999.0764.
PubMed 10744938Langer FB, Wenzl E, Prager G, Salat A, Miholic J, Mang T, Zacherl J. Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent. Ann Thorac Surg. 2005 Feb;79(2):398-403; discussion 404. doi: 10.1016/j.athoracsur.2004.07.006.
PubMed 15680802
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Gastric Cancer Patients After Total Gastrectomy: A Prospective Randomized Control Trial (DOPGT_2015)
- ClinicalTrials.gov ID
- NCT03257280
- Acronym / sponsor ID
- DOPGT_2015
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 22 Aug 2017 (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.
This is a prospective randomized controlled clinical trial to clarify the effect of early oral nutrition introduction after total gastrectomy in gastric cancer patients on the length of hospital stay, comparing an experimental group vs control group.
Detailed description
The total gastrectomy is a high complexity surgery that involves a high morbid-mortality. In our center, the postoperative management consisted in 1 week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a progressive oral diet is begin.
In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was introduced in the surgical patients attempting to improve their postoperative course. This new concept includes the preoperative advices related to the surgery, the intensive mobilization after surgery, the early oral diet, and to avoid the routinary use of the nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is still no good evidence to sport these practice.
Based on the reasons exposed before, the investigators design a prospective randomized controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and if no evidence of drainage leakage the participants will be randomized into two groups: one of them with our classical postoperative management, and the other one implements an early oral nutrition protocol, having in considerations its effectiveness, security, and impact on the hospital stay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral nutrition | Experimental | Other: Early oral nutritionAn early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy. |
| control group | No intervention | –In our center, the classical postoperative management consisted in one week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a three days progressive oral diet is begin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients requiring radical total gastrectomy for gastric cancer.
- 18 or above years old.
- Acceptance and signing the full informed consent.
Key exclusion criteria (7 listed)
- Patient with poorly controlled diabetes mellitus (glycosylated hemoglobin levels greater than 7%)
- Emergency surgery.
- Total gastrectomy with esophagus-jejunal manual suture.
- Early dehiscence of esophagus-jejunal anastomosis (first 24 hours).
- Reintervention for abdominal complication in the first 24 hours.
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 |
|---|---|---|
| Early oral nutritionAn early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy. | Other | Early oral nutrition |
Primary outcome
Hospital stay
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Postoperatory hospital stay in days
13 secondary outcomes
Mortality
Time frame: During the admission, two weeks and one month after surgery
Hospital readmissions
Time frame: Two weeks and one month after surgery
Weight
Time frame: First day of hospital admission, two weeks and one month after surgery
Anastomotic dehiscence
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Duodenal stump leak
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Paralytic ileus
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Intra-Abdominal abscesses
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Postoperative Hemoperitoneum
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Evisceration
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Superficial Incisional Surgical Site Infection
Time frame: postoperative 1 day to discharge, up to 1 month after surgery
Height
Time frame: First day of hospital admission, two weeks and one month after surgery
Percentage of weight lost
Time frame: First day of hospital admission, two weeks and one month after surgery
Impedancemetry
Time frame: First day of hospital admission, two weeks and one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 21918974Gonzalez CA, Agudo A. Carcinogenesis, prevention and early detection of gastric cancer: where we are and where we should go. Int J Cancer. 2012 Feb 15;130(4):745-53. doi: 10.1002/ijc.26430. Epub 2011 Oct 20.
- Background: PubMed 21705456Allum WH, Blazeby JM, Griffin SM, Cunningham D, Jankowski JA, Wong R; Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, the British Society of Gastroenterology and the British Association of Surgical Oncology. Guidelines for the management of oesophageal and gastric cancer. Gut. 2011 Nov;60(11):1449-72. doi: 10.1136/gut.2010.228254. Epub 2011 Jun 24. No abstract available.
- Background: PubMed 21633049Van Cutsem E, Dicato M, Geva R, Arber N, Bang Y, Benson A, Cervantes A, Diaz-Rubio E, Ducreux M, Glynne-Jones R, Grothey A, Haller D, Haustermans K, Kerr D, Nordlinger B, Marshall J, Minsky BD, Kang YK, Labianca R, Lordick F, Ohtsu A, Pavlidis N, Roth A, Rougier P, Schmoll HJ, Sobrero A, Tabernero J, Van de Velde C, Zalcberg J. The diagnosis and management of gastric cancer: expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2010. Ann Oncol. 2011 Jun;22 Suppl 5:v1-9. doi: 10.1093/annonc/mdr284.
- Background: PubMed 22449155Viudez-Berral A, Miranda-Murua C, Arias-de-la-Vega F, Hernandez-Garcia I, Artajona-Rosino A, Diaz-de-Liano A, Vera-Garcia R. Current management of gastric cancer. Rev Esp Enferm Dig. 2012 Mar;104(3):134-41. doi: 10.4321/s1130-01082012000300006.
- Background: PubMed 20555102Okines A, Verheij M, Allum W, Cunningham D, Cervantes A; ESMO Guidelines Working Group. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v50-4. doi: 10.1093/annonc/mdq164. No abstract available.
- Background: PubMed 22362071Wong J, Kelly KJ, Mittra A, Gonen M, Allen P, Fong Y, Coit D. Rt-PCR increases detection of submicroscopic peritoneal metastases in gastric cancer and has prognostic significance. J Gastrointest Surg. 2012 May;16(5):889-96; discussion 896. doi: 10.1007/s11605-012-1845-2. Epub 2012 Feb 24.
- Background: PubMed 24305936Takata A, Kurokawa Y, Fujiwara Y, Nakamura Y, Takahashi T, Yamasaki M, Miyata H, Nakajima K, Takiguchi S, Mori M, Doki Y. Prognostic value of CEA and CK20 mRNA in the peritoneal lavage fluid of patients undergoing curative surgery for gastric cancer. World J Surg. 2014 May;38(5):1107-11. doi: 10.1007/s00268-013-2385-y.
- Background: PubMed 20882416Washington K. 7th edition of the AJCC cancer staging manual: stomach. Ann Surg Oncol. 2010 Dec;17(12):3077-9. doi: 10.1245/s10434-010-1362-z. No abstract available.
- Background: PubMed 21573742Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
- Background: PubMed 23801867Feng F, Ji G, Li JP, Li XH, Shi H, Zhao ZW, Wu GS, Liu XN, Zhao QC. Fast-track surgery could improve postoperative recovery in radical total gastrectomy patients. World J Gastroenterol. 2013 Jun 21;19(23):3642-8. doi: 10.3748/wjg.v19.i23.3642.
- Background: PubMed 22415758Deguchi Y, Fukagawa T, Morita S, Ohashi M, Saka M, Katai H. Identification of risk factors for esophagojejunal anastomotic leakage after gastric surgery. World J Surg. 2012 Jul;36(7):1617-22. doi: 10.1007/s00268-012-1559-3.
- Background: PubMed 23099730Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Piccione F, Amicucci G. Prevention of anastomotic leakage after total gastrectomy with perioperative supplemental oxygen administration: a prospective randomized, double-blind, controlled, single-center trial. Ann Surg Oncol. 2013 May;20(5):1584-90. doi: 10.1245/s10434-012-2714-7. Epub 2012 Oct 26.
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.
Leandre Farran Teixidor, PhD, MD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early oral nutrition in people with Early Oral Nutrition After Total Gastrectomy and Gastric Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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 Spain. 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 Leandre Farran Teixidor, PhD, MD (+34-93-335-90-11 ext. 2316, lfarran@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital stay (time frame: postoperative 1 day to discharge, up to 1 month 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 NCT03257280, which also lists 36 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 17 Feb 2021.