Petersen's HerniaNCT05105360
Prevention of Petersen's Hernia After Laparoscopic Gastrectomy
A study testing Closure method of Petersen's space and Mesentery fixation method in people with Petersen's Hernia, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Petersen's Hernia
- What is being tested?
- Closure method of Petersen's space and Mesentery fixation method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2022to 26 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- : 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
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- 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
Who cannot join
- 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.
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- 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;
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gyeongsang National University Hospital
Changwon, Gyeongsandnam-do, 51472
About this study
Official title: Prevention of Petersen's Hernia After Laparoscopic Gastrectomy for Gastric Cancer, Prospective, Multicenter Trial
- 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
Read the detailed description
- Background
- Petersen's hernia after gastrectomy Petersen's hernia was reported in 1900 by German surgeon Walther Petersen following the occurrence of an internal hernia after gastrectomy and gastrojejunostomy (G-J) 1[]. Petersen's hernia occurs in the free space posterior to a G-J site after any type of G-J and is caused by herniation of the small bowel through the defect between the small bowel mesentery and the transverse mesocolon. As shown in CT figure in Figure 1, the small bowel mesentery rotates and twists, leading to an emergency situation in which necrosis of the entire small intestine occurs due to decreased blood circulation of the small intestine The occurrence rate of Petersen's hernias after laparoscopic Roux-en-Y G-J is approximately 1.7~9.7%
- Peterson's hernia can occur in the RNY esophagojejunal anastomosis after gastrectomy, or after the RNY gastrojejunostomy and Billroth type 2 anastomosis after distal gastrectomy. Also, it can occur after the obesity surgery RNY gastric bypass surgery.
- The incidence of internal hernia has been reported to be higher in laparoscopic approaches than in open gastrectomy One possible cause of the increasing incidence of Petersen's hernias is the recent development of minimally invasive surgery. A higher incidence of internal hernia is reported in minimally invasive gastrectomy than in open gastrectomy. After open surgery, adhesion was made between the small bowel and the operative wound site, however with minimally invasive surgery, adhesion is remarkably decreased, not only because of the disappearance of the open wound in the upper abdomen but also the use of antiadhesive agent Therefore, non-absorbable sutures require the closure of Peterson's spaces, and according to report of Blockhuys M, the frequency of internal hernia decreased after closure of Petersen's space. The frequency of internal hernia significantly decreases when Peterson space closure is implemented compared to the group that performed mesentery defect closure only.
- The problem of Petersen's space closure procedure The closure of the defect at Petersen's space can induce bleeding by injuring the mesenteric vessels, as well as small bowel ischemia, caused by injuring the peripheral mesenteric vessels near the small bowel lumen. It has also been reported that early postoperative obstruction could be due to jejunal kinking of the closing site of the mesenteric defect. The closure of mesenteric defects increased the risk for severe postoperative complications in the early postoperative phase (<30 days) following the closure, mainly because of kinking of the jejunostomy site. We also encountered kinking of the jejunojejunostomy in the early postoperative periods after gastrectomy. However, it is not easy to determine if the complications are because of kinking of the entero-entero anastomosis or the adhesion effect from the closure of Petersen's space. Peterson space closure is necessary, but it is difficult by technical problem to develop an easy method.
- Previous study We conducted jejunal mesentery fixing (Mefix) to the transverse mesocolon with a non-absorbable suture to prevent of a Petersen's hernia.
The theory of the Mefix method is as follows. When the mesentery of the small intestine is fixed to the transverse mesocolon between the small bowel and the colon mesentery, the defect still remains. However, the small bowel does not enter the defect because the small bowel mesentery is fixed at the transverse mesocolon; consequently, a Petersen's hernia does not occur.
MEFIX method allowed partial herniation of bowel, but it prevent of total herniation. This prevent bowel infarction
We closed Petersen's space defect between March 1st, 2016 and Dec 31th, 2017 (N=49), and we performed the Mefix procedure between July 1st, 2017 and June 30th, 2018 (N=26). We classified patients into the Petersen's space closure group (closure group) and the mesentery fixing group (Mefix group). All patients visited the hospital at six months and one year after surgery, and a CT scan was performed to check for the recurrence of gastric cancer. We determined the incidence of Petersen's hernia by abdominal CT scan, and we found no incidence of Petersen's hernias in either group. The procedure times for mesentery fixing (3.7 ± 1.1 minutes) were significantly shorter than those for Petersen's space closures (7.5 ± 1.5 minutes) (p<0.001). However, a retrospective study and a small group of patients seem to require a large, prospective random study.
- Conditions
- Petersen's Hernia
- Being tested
- Closure method of Petersen's space, Mesentery fixation method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure method of Petersen's spaceProcedure or surgery
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).
Mesentery fixation methodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Petersen's closure group | Active comparator | Petersen's space closure method Receives: Procedure: Closure method of Petersen's space |
| Mefix group | Experimental | Mesentery fixation method Receives: Procedure: Mesentery fixation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative 3-yr Petersen's hernia incidence
Petersen's hernia incidence with operation for hernia reduction due to severe abdominal pain
Measured: post-operative 3-yr
Secondary outcomes (4)
Postoperative morbidity and bowel obstruction incidence
incidence of intestinal obstruction and complication
Measured: complication within 30 days after surgery
subgroup analysis of antiadhesive agent use
subgroup analysis of incidence of intestinal obstruction by antiadhesive agent use
Measured: complication within 30 days after surgery
subgroup analysis of gastrectomy range and reconstruction method
subgroup analysis of incidence of complication by gastrectomy range and reconstruction method
Measured: complication within 30 days after surgery
post-operative 5-yr Petersen's hernia incidence
Petersen's hernia incidence with operation for hernia reduction due to severe abdominal pain
Measured: post-operative 5-yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Apr 2022
- Primary completion26 Jan 2027 (estimated)
- Study completion26 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Petersen's HerniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-inferior study, multicenter, prospective, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Sangho Jeong, MD, Study chair, Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105360
- Sponsor's protocol ID
- Mefix study
- Status last verified
- Mar 2025
- First submitted
- 22 Oct 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The using of data is possible if the principle investigaster was accept of other researchers study plan.
Publications
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.
PubMed 33269633Park 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.
PubMed 38167216
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Petersen's Hernia After Laparoscopic Gastrectomy for Gastric Cancer, Prospective, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05105360
- Acronym / sponsor ID
- Mefix study
- Conditions
- Petersen's Hernia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 26 Jan 2029 (estimated)
- First posted
- 3 Nov 2021 (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.
- 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
Detailed description
- Background
- Petersen's hernia after gastrectomy Petersen's hernia was reported in 1900 by German surgeon Walther Petersen following the occurrence of an internal hernia after gastrectomy and gastrojejunostomy (G-J) 1[]. Petersen's hernia occurs in the free space posterior to a G-J site after any type of G-J and is caused by herniation of the small bowel through the defect between the small bowel mesentery and the transverse mesocolon. As shown in CT figure in Figure 1, the small bowel mesentery rotates and twists, leading to an emergency situation in which necrosis of the entire small intestine occurs due to decreased blood circulation of the small intestine The occurrence rate of Petersen's hernias after laparoscopic Roux-en-Y G-J is approximately 1.7~9.7%
- Peterson's hernia can occur in the RNY esophagojejunal anastomosis after gastrectomy, or after the RNY gastrojejunostomy and Billroth type 2 anastomosis after distal gastrectomy. Also, it can occur after the obesity surgery RNY gastric bypass surgery.
- The incidence of internal hernia has been reported to be higher in laparoscopic approaches than in open gastrectomy One possible cause of the increasing incidence of Petersen's hernias is the recent development of minimally invasive surgery. A higher incidence of internal hernia is reported in minimally invasive gastrectomy than in open gastrectomy. After open surgery, adhesion was made between the small bowel and the operative wound site, however with minimally invasive surgery, adhesion is remarkably decreased, not only because of the disappearance of the open wound in the upper abdomen but also the use of antiadhesive agent Therefore, non-absorbable sutures require the closure of Peterson's spaces, and according to report of Blockhuys M, the frequency of internal hernia decreased after closure of Petersen's space. The frequency of internal hernia significantly decreases when Peterson space closure is implemented compared to the group that performed mesentery defect closure only.
- The problem of Petersen's space closure procedure The closure of the defect at Petersen's space can induce bleeding by injuring the mesenteric vessels, as well as small bowel ischemia, caused by injuring the peripheral mesenteric vessels near the small bowel lumen. It has also been reported that early postoperative obstruction could be due to jejunal kinking of the closing site of the mesenteric defect. The closure of mesenteric defects increased the risk for severe postoperative complications in the early postoperative phase (<30 days) following the closure, mainly because of kinking of the jejunostomy site. We also encountered kinking of the jejunojejunostomy in the early postoperative periods after gastrectomy. However, it is not easy to determine if the complications are because of kinking of the entero-entero anastomosis or the adhesion effect from the closure of Petersen's space. Peterson space closure is necessary, but it is difficult by technical problem to develop an easy method.
- Previous study We conducted jejunal mesentery fixing (Mefix) to the transverse mesocolon with a non-absorbable suture to prevent of a Petersen's hernia.
The theory of the Mefix method is as follows. When the mesentery of the small intestine is fixed to the transverse mesocolon between the small bowel and the colon mesentery, the defect still remains. However, the small bowel does not enter the defect because the small bowel mesentery is fixed at the transverse mesocolon; consequently, a Petersen's hernia does not occur.
MEFIX method allowed partial herniation of bowel, but it prevent of total herniation. This prevent bowel infarction
We closed Petersen's space defect between March 1st, 2016 and Dec 31th, 2017 (N=49), and we performed the Mefix procedure between July 1st, 2017 and June 30th, 2018 (N=26). We classified patients into the Petersen's space closure group (closure group) and the mesentery fixing group (Mefix group). All patients visited the hospital at six months and one year after surgery, and a CT scan was performed to check for the recurrence of gastric cancer. We determined the incidence of Petersen's hernia by abdominal CT scan, and we found no incidence of Petersen's hernias in either group. The procedure times for mesentery fixing (3.7 ± 1.1 minutes) were significantly shorter than those for Petersen's space closures (7.5 ± 1.5 minutes) (p<0.001). However, a retrospective study and a small group of patients seem to require a large, prospective random study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-inferior study, multicenter, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Petersen's closure group | Active comparator | Procedure: Closure method of Petersen's spacePetersen's space closure method |
| Mefix group | Experimental | Procedure: Mesentery fixation methodMesentery fixation method |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- : 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
Key exclusion criteria (13 listed)
- active double cancer (synchronous and metachronous double cancer within 5 disease-free years),
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 |
|---|---|---|
| Closure method of Petersen's spaceSurgeons 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). | Procedure or surgery | Petersen's closure group |
| Mesentery fixation methodSurgeons 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. | Procedure or surgery | Mefix group |
Primary outcome
post-operative 3-yr Petersen's hernia incidence
Time frame: post-operative 3-yr
Petersen's hernia incidence with operation for hernia reduction due to severe abdominal pain
4 secondary outcomes
Postoperative morbidity and bowel obstruction incidence
Time frame: complication within 30 days after surgery
subgroup analysis of antiadhesive agent use
Time frame: complication within 30 days after surgery
subgroup analysis of gastrectomy range and reconstruction method
Time frame: complication within 30 days after surgery
post-operative 5-yr Petersen's hernia incidence
Time frame: post-operative 5-yr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Results publication: PubMed 33269633Min 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.
- Derived from this study: PubMed 38167216Park 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.
- Individual participant dataSharing planned: No. The using of data is possible if the principle investigaster was accept of other researchers study plan.
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.
Sangho Jeong, MD study chair
Gyeongsang National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure method of Petersen's space and Mesentery fixation method in people with Petersen's Hernia, run by Gyeongsang National University Hospital at 1 site in South Korea.
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 9 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
post-operative 3-yr Petersen's hernia incidence (time frame: post-operative 3-yr). 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 NCT05105360, which also lists 2 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 13 Mar 2025.