NCT05105360

Brief Summary

  • 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2022Jan 2029

First Submitted

Initial submission to the registry

October 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2029

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

October 22, 2021

Last Update Submit

March 11, 2025

Conditions

Petersen's Hernia

Outcome Measures

Primary Outcomes (1)

  • post-operative 3-yr Petersen's hernia incidence

    Petersen's hernia incidence with operation for hernia reduction due to severe abdominal pain

    post-operative 3-yr

Secondary Outcomes (4)

  • Postoperative morbidity and bowel obstruction incidence

    complication within 30 days after surgery

  • subgroup analysis of antiadhesive agent use

    complication within 30 days after surgery

  • subgroup analysis of gastrectomy range and reconstruction method

    complication within 30 days after surgery

  • post-operative 5-yr Petersen's hernia incidence

    post-operative 5-yr

Study Arms (2)

Petersen's closure group

ACTIVE COMPARATOR

Petersen's space closure method

Procedure: Closure method of Petersen's space

Mefix group

EXPERIMENTAL

Mesentery fixation method

Procedure: Mesentery fixation method

Interventions

Closure method of Petersen's spacePROCEDURE

Surgeons closed Petersen's space between the mesentery of the jejunal Roux limb and the mesentery of the transverse colon at the posterior side of esophago-jejunostomy or gastro-jejunostomy from the mesentery root to the bowel side using a nonabsorbable barbed suture V-LocTM 3-0 (Medtronic VR, Minneapolis, MN, USA).

Petersen's closure group
Mesentery fixation methodPROCEDURE

Surgeons fixed the jejunal mesentery (jejunojejunostomy\[J-J\] distal 30 cm) to the transverse mesocolon using non-absorbable barbed suture VLocTM 3-0 sutures. The suture area was exposed by grasping the jejunum side mesentery (jejunal side, at site 30cm distal J-J) and the transverse mesocolon (colonic side). The jejunal side mesentery was fixed to the colonic side mesocolon between the jejunum and the transverse colon using nonabsorbable barbed V-LocTM 3-0 sutures.The suture started between jejunal mesentery just below of SMA vascular arcade and transverse mesocolon, and it finished when it reaches the root of the mesentery. To anchor the mesentery, continuous suturing with V-Loc two-point backward sutures were performed at the final step.

Mefix group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • : 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyeongsang National University Hospital

Changwon, Gyeongsandnam-do, 51472, South Korea

Location

Related Publications (2)

  • Min JS, Jeong SH, Park JH, Kim TH, Hong SC, Jung EJ, Ju YT, Jeong CY, Lee JK, Park M, Lee YJ. Prevention of Petersen's hernia using jejunal mesentery fixing (Mefix). Minim Invasive Ther Allied Technol. 2022 Apr;31(4):580-586. doi: 10.1080/13645706.2020.1848872. Epub 2020 Dec 3.

    PMID: 33269633RESULT

  • Park JK, Kim DH, Jeon TY, Jeong SH, Kim TH, Min JS, Kim RB, Lee YJ, Park JH, Son YG, Yoon KY, Seo KW, Kim KH, Kim Y, Chae HD, Hwang SH, Lee SH, Chung JH, Kim HI, Park DJ, Kim KH, Seo SH, Oh SJ, Lee WY, In Choi C. Comparison between the mesenteric fixation method (MEFIX) and conventional methods at preventing the occurrence of Petersen's hernia: a study protocol for a multicenter randomized controlled trial. Trials. 2024 Jan 2;25(1):7. doi: 10.1186/s13063-023-07841-9.

    PMID: 38167216DERIVED

Study Officials

  • Sangho Jeong, MD

    Gyeongsang National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: non-inferior study, multicenter, prospective, randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 3, 2021

Study Start

April 1, 2022

Primary Completion (Estimated)

January 26, 2027

Study Completion (Estimated)

January 26, 2029

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The using of data is possible if the principle investigaster was accept of other researchers study plan.

Locations

KR(1)