Clinical trial · Interventional
Protocol: Reconstruct the Pelvic Peritoneum Using BPF
Pelvic Peritoneum Reconstruction Using the Bladder Peritoneum Flap in Laparoscopic Extralevator Abdominoperineal Excision --- A Multi-center, Prospective Single-Arm Cohort Study (IDEAL Phase 2A)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Extralevator abdominoperineal excision (ELAPE) may cause various surgical complications including disruption of perineal wound, perineal hernia and adhesive small-bowel obstruction. Pelvic peritoneum reconstruction could prevent those complications, but it may not always be achievable, especially in patients with severe pelvic fibrosis after neoadjuvant radiotherapy. Previous study has reported the application of the pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE. The aim of the study is to evaluate the short-term clinical, technical and safety outcomes of pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE. Methods/Design: This is a single -center prospective cohort study and fulfill the IDEAL 2A stage principle. Rectal cancer patients after neoadjuvant radiotherapy and about to undergo laparoscopic ELAPE will be included. Main exclusion criteria are being complicated with urgent complications, ASA grade \> 3 and accompanied with mental illness. Patients suffering rigid pelvis or huge perineal peritoneum defect, and having difficulty in primary perineal wound closure will be considered eligible for the baldder peritoneum flap (BPF) group; corresponding rectal cancer patients will be allocated to the control group. After informed consent, 10 patients are planned to be included in the BPF group. Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using BPF are to be performed. The surgical safety is to be evaluated after one-year follow-up. Primary endpoints are the occurrence of intraoperative and postoperative complications of pelvic peritoneum reconstruction after ELAPE. Second endpoints are overall complication rate within 30 days after surgery, extent of small intestine falling down to pelvic cavity, and other follow-up consequences within 1 year after surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BPF group
- description
- Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
- interventionNames
- Procedure: Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
- type
- NO_INTERVENTION
- label
- control group
- description
- Regarding to the pelvic peritoneum reconstruction, in control group, the pelvic peritoneum will be closed with running suturing. If not possible, the peritoneum covering the surface of the bladder will be secured on the anterior surface of the sacrum with nonabsorbable sutures at the level where the anatomic structure obliterates the pelvic entrance. If neither method was feasible, the pelvic peritoneum defect will be left unclosed.
Primary outcomes (4)
- measure
- intraoperative complications
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients aged between 18 to 75. * ASA grade ≤ 3. * Pathology confirmed as rectal adenocarcinoma; * Lower rectal cancer with neoadjuvant (chemo)radiotherapy, and an APR was needed; * The pelvic peritoneum can't be close by direct suture; * Patients being able to understand the study protocol and willing to participate in the study, providing written informed consent. Exclusion Criteria: * Bladder invaded by tumor or primary bladder cancer. * severe systemic diseases abibuffecting wound healing (e.g. diabetes, liver cirrhosis or immune compromised status like HIV) * Sensitivity to anti-adhesion barrier. * Peritoneal implantation. * History of severe mental illness. * Continuous systemic steroid therapy recent 1 month
References
Publications (9)
- BACKGROUNDHolm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489. PMID 17143848
- BACKGROUNDYang T, Wei M, Deng X, Meng W, Wang Z. A Novel Laparoscopic Technique With a Bladder Peritoneum Flap Closure for Pelvic Cavity for Patients With Rigid Pelvic Peritoneum After Neoadjuvant Radiotherapy in Laparoscopic Extralevator Abdominoperineal Excision. Dis Colon Rectum. 2019 Sep;62(9):1136-1140. doi: 10.1097/DCR.0000000000001435. PMID 31318767
- BACKGROUNDAggarwal N, Seshadri RA, Arvind A, Jayanand SB. Perineal Wound Complications Following Extralevator Abdominoperineal Excision: Experience of a Regional Cancer Center. Indian J Surg Oncol. 2018 Jun;9(2):211-214. doi: 10.1007/s13193-018-0741-y. Epub 2018 Apr 14. PMID 29887703
- BACKGROUNDButt HZ, Salem MK, Vijaynagar B, Chaudhri S, Singh B. Perineal reconstruction after extra-levator abdominoperineal excision (eLAPE): a systematic review. Int J Colorectal Dis. 2013 Nov;28(11):1459-68. doi: 10.1007/s00384-013-1660-6. Epub 2013 Feb 26. PMID 23440362
- BACKGROUNDMcCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK; IDEAL Group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2013 Jun 18;346:f3012. doi: 10.1136/bmj.f3012. PMID 23778427
- BACKGROUNDBengtsson S, Hambraeus A, Laurell G. Wound infections after surgery in a modern operating suite: clinical, bacteriological and epidemiological findings. J Hyg (Lond). 1979 Aug;83(1):41-57. doi: 10.1017/s002217240002581x. PMID 379212
- BACKGROUNDChristensen HK, Nerstrom P, Tei T, Laurberg S. Perineal repair after extralevator abdominoperineal excision for low rectal cancer. Dis Colon Rectum. 2011 Jun;54(6):711-7. doi: 10.1007/DCR.0b013e3182163c89.