Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-03-23
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Elimination of Peritoneal Tumor Cells With Extensive Peritoneal Lavage During Surgery in Patients With Gastric Cancer
NCT01476553
Development of an IDEAL Framework to Standardise Cytoreductive Surgery for Colorectal Peritoneal Metastases
NCT03733184
The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration
NCT04948879
Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy
NCT05134142
APEMESH II - Perineal Reconstruction
NCT04779125
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Reconstruction the pelvic peritoneum could prevent the small intestine adhering to the true pelvis by keeping it in the abdominal cavity, thus decrease the occurrence of ASBO and other perineal complications. However, pelvic peritoneum reconstruction may not always be feasible especially in those patients who had received a neoadjuvant radiotherapy and suffered severe tissue fibrosis or those patients who have a large defect of pelvic peritoneum.
Recently the investigators have reported a novel method to reconstruct the pelvic peritoneum under laparoscope in patients with a rigid pelvis. A bladder peritoneum flap was used to cover the defect of pelvic peritoneum. Previous attempts have proved the feasibility of the pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE. This protocol is a further study to verify its short-term clinical, technical and safety outcomes.
The objective of this study is to evaluate the short-term clinical, technical and safety outcomes of pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic ELAPE.
This is a multi-center, prospective development study. The method of PPR using the bladder peritoneum flap in laparoscopic ELAPE is at the development stage. And this protocol fulfills the requirement of IDEAL framework stage 2A. Approval of the ethics committee has been obtained from the ethics committee of West China Hospital, Sichuan University (2019 No. 194). The present study was registered on the clinicaltrials.gov. Any technology amendments will be presented to the institutional review board for further assessment. Benefits and risks of the study will be informed to participants. Only participants who signed an informed consent form and agree to participate will be included in this study. Participants have the right to quit the study at any time without any reason. In emergency circumstances, surgeons have the right to end the study. Data of the details will be stored in a database and published after the trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BPF group
Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
control group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
West China Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ziqiang Wang,MD
Director of Department of Gastrointestinal Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ziqiang Wang
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West China Hospital
Chengdu, Sichuan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Holm 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.
Yang 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.
Aggarwal 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.
Butt 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.
McCulloch 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.
Bengtsson 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.
Christensen 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.
Shen Y, Yang T, Deng X, Yang J, Meng W, Wang Z. Pelvic peritoneum reconstruction using the bladder peritoneum flap in laparoscopic extralevator abdominoperineal excision: A multi-center, prospective single-arm cohort study (IDEAL Phase 2A). Medicine (Baltimore). 2020 Jun 19;99(25):e20712. doi: 10.1097/MD.0000000000020712.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MC-SA-2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.