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NCT05105360Active, not recruiting

Prevention of Petersen's Hernia After Laparoscopic Gastrectomy

Prevention of Petersen's Hernia After Laparoscopic Gastrectomy for Gastric Cancer, Prospective, Multicenter Trial

Source: ClinicalTrials.gov · Last updated 13 Mar 2025

Brief summary (registry, in English)

* Aim of this study To compare the cases underwent operation to treat intestinal obstruction caused by Peterson hernia within 3 years after laparoscopic gastrectomy between closure method and Mefix methods. * Primary end point: The cases underwent operation to treat intestinal obstruction caused by Peterson hernia within 3 years after laparoscopic gastrectomy was not- inferior between Closure and MEFIX. * Secondary endpoint: Procedures' times (minutes), bleeding, Hospital stays (days) Occurrence of postoperative small bowel obstruction within 30 days after surgery, Short-term complications within 30 days after surgery, Occurrence of Petersen's Hernia according to the use of anti-adhesion agents, anastomotic methods, CLOSURE or MEFIX previous surgical suture condition, hernia degree, and bowel condition (strangulation, perforation) at the timing of emergent operation for treatment of Petersen's Hernia obstructions

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
444 (estimated)
First submitted
22 Oct 2021
Start date
1 Apr 2022
Primary completion date
26 Jan 2027
Lead sponsor
Gyeongsang National University Hospital
NCT number
NCT05105360

What you commit to

  • Study type: Interventional
  • Planned participants: 444
  • From 1 Apr 2022 to the primary completion date, 26 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • active double cancer (synchronous and metachronous double cancer within 5 disease-free years),
    • carcinoma in situ,
    • open gastrectomy,
    • reconstructed by Billroth I procedure,
    • gastric cancer recurrence, ;a history of gastrectomy. ;
    • a patient who has the history of abdominal surgery except laparoscopic appendectomy and gallbladder resection, and laparoscopic gynecologic surgery due to benign disease, and Cesarean section.
    • a patient who need co-ordination for other organs in preoperative examination (However, laparoscopic cholecystectomy is included in the selection criteria due to gallbladder polyps, and gallbladder disease).
    • Pregnant women, lactating women
    • a patient with mental illness (a person diagnosed with mental illness in medical records)
    • a patient who are taking corticosteroid whole-body (including herbal medicine)
    • a patient who has an uncontrolled history of angina or myocardial infarction within six months of the study;
    • uncontrolled hypertension
    • a patient who has a serious respiratory disease that requires continuous oxygen therapy;

Who the study is looking for

  • : histological proven primary gastric adenocarcinoma
  • no evidence of other distant metastasis
  • R0 resection
  • laparoscopic or robotic gastrectomy
  • and reconstructed by Roux-en-Y reconstruction or the Billroth II procedure
  • patient with appropriate conditions of activity; 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • patient who have not previously received chemotherapy or radiation treatment in the abdomen.
  • patinet who signed the consent form
  • cTNM stage I or II or III

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gyeongsang National University Hospital
Coordinator of this site? Confirm its status
ChangwonSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.