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Perineal reconstruction and stoma reinforcement with Strattice

Strattice

Baljit Singh, FRCS, FACS

Sanjay Chaudhri, FRCS

Per J Nilsson, MD

Pierre J Maina, MD

W Bemelman, MD

This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.

About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.

Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement

Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.

Stoma will be assessed for herniation at Months 3, 6, 12 and 24

Karolinska University Hospital

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Slagelse Hospital

University Hospitals, Leicester

Carcinoma

Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.

Pelvic floor Reconstruction

Tang Bo, MD

Li Chuan, MD

Tang Bo, M.D/Ph.D

The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.

Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).

We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.

PR in Endoscopic LAR for Rectal Cancer

Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer

Southwest Hospital, China

Secretary of General Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement	NCT01670851	Rectal Cancer	Strattice	18 Years -	University Hospitals, Leicester
PR in Endoscopic LAR for Rectal Cancer	NCT04078828	Rectal Carcinom...	Pelvic floor Re...	18 Years - 75 Years	Southwest Hospital, China

Spots Global Cancer Trial Database for pelvic floor reconstruction