Rectal Prolapse With ODS. STARR vs LVR.

NCT04892108 | Completed

• 1 other identifier: 129/2021/Sper/AOUFe
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).

Conditions

Rectal Prolapse; Defecation Disorder; Rectocele; Female; Surgery

Keywords

Obstructed defecation syndrome; Transanal rectal prolassectomy; Laparoscopic ventral mesh rectopexy

Outcome Measures

Primary Outcomes (1)

• Evaluation of different outcomes in relief from ODS after surgery in both groups

  In order to evaluate the short- and long-term efficacy of STARR procedure compared to LVR, the percentage of changes in total ODS, PAC-QoL, PFDI, PFQI, Wexner Constipation, the Cleveland Clinic Fecal Incontinence (CCFI) scores between baseline and 6, 12, 24, 36, and 48 months after surgery, were adopted as primary outcome.

  4 years

Secondary Outcomes (5)

• short-term postoperative complications (within 30 days after surgery)

  4 years

• long-term postoperative complications

  4 years

• recurrence or persistence of rectal prolapse

  4 years

• recurrence or persistence of ODS (Obstructed defecation syndrome)

  4 years

• patient satisfaction in terms of pain

  4 years

Study Arms (2)

Group STARR

EXPERIMENTAL

Patients undergoing transanal prolassectomy with mechanical stapler (STARR: Stapled Trans Anal Rectal Resection) randomly

Procedure: STARR (Stapled Trans Anal Rectal Resection)

Group LVR

EXPERIMENTAL

Patients undergoing Laparoscopic suspensory correction of rectal prolapse by ventral rectopexy with biological prosthesis (LVR) randomly

Procedure: LVR (Laparoscopic Ventral Rectopexy)

Interventions

STARR (Stapled Trans Anal Rectal Resection) PROCEDURE

Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)

Group STARR

LVR (Laparoscopic Ventral Rectopexy) PROCEDURE

Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)

Group LVR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female gender,
• the presence of rectorectal or rectoanal intussusception as main cause of ODS, confirmed by defecography,
• type of operation performed (STARR or LVR),
• ODS score \> 14 \[17\]
• PACQoL \>32 \[18\]
• ODS symptoms for at least 12 months prior to enrollment
• Failure of at least 6 months of medical therapy

You may not qualify if:

• male gender,
• severe fecal incontinence (CCS score\>6, Maximum Resting Pressure at rectal manometry \< 50 mmHg),
• combined procedures
• previous surgery on rectum or anus for cancer or rectal prolapse, inflammatory bowel disease, other type of surgery to relieve ODS
• pregnancy,
• anismus or dissinergic defecation
• full-thickness prolapse
• stress urinary incontinence associated
• histerocele or cystocele associated (since we usually correct both defects in the same surgical procedure)
• prior pelvic radiotherapy
• slow transit constipation defined as ≤ 2 bowel movements per week,
• any psychiatric diseases.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Surgery 2 Surgical Department, Sant'Anna University Hospital Ferrara, Italy

Ferrara, 44124, Italy

Location

Related Publications (19)

• Hicks CW, Weinstein M, Wakamatsu M, Savitt L, Pulliam S, Bordeianou L. In patients with rectoceles and obstructed defecation syndrome, surgery should be the option of last resort. Surgery. 2014 Apr;155(4):659-67. doi: 10.1016/j.surg.2013.11.013. Epub 2013 Dec 5.

  PMID: 24508117 BACKGROUND

• Khaikin M, Wexner SD. Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. doi: 10.3748/wjg.v12.i20.3168.

  PMID: 16718835 BACKGROUND

• Rao SS. Dyssynergic defecation. Gastroenterol Clin North Am. 2001 Mar;30(1):97-114. doi: 10.1016/s0889-8553(05)70169-2.

  PMID: 11394039 BACKGROUND

• Podzemny V, Pescatori LC, Pescatori M. Management of obstructed defecation. World J Gastroenterol. 2015 Jan 28;21(4):1053-60. doi: 10.3748/wjg.v21.i4.1053.

  PMID: 25632177 BACKGROUND

• Gunner CK, Senapati A, Northover JM, Brown SR. Life after PROSPER. What do people do for external rectal prolapse? Colorectal Dis. 2016 Aug;18(8):811-4. doi: 10.1111/codi.13255.

  PMID: 27481719 BACKGROUND

• Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177.

  PMID: 23461778 BACKGROUND

• Emile SH, Elfeki H, Shalaby M, Sakr A, Sileri P, Wexner SD. Perineal resectional procedures for the treatment of complete rectal prolapse: A systematic review of the literature. Int J Surg. 2017 Oct;46:146-154. doi: 10.1016/j.ijsu.2017.09.005. Epub 2017 Sep 7.

  PMID: 28890414 BACKGROUND

• van den Esschert JW, van Geloven AA, Vermulst N, Groenedijk AG, de Wit LT, Gerhards MF. Laparoscopic ventral rectopexy for obstructed defecation syndrome. Surg Endosc. 2008 Dec;22(12):2728-32. doi: 10.1007/s00464-008-9771-9. Epub 2008 Mar 5.

  PMID: 18320283 BACKGROUND

• Altomare DF, Spazzafumo L, Rinaldi M, Dodi G, Ghiselli R, Piloni V. Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome. Colorectal Dis. 2008 Jan;10(1):84-8. doi: 10.1111/j.1463-1318.2007.01262.x. Epub 2007 Apr 18.

  PMID: 17441968 BACKGROUND

• Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.

  PMID: 16036506 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Cariou de Vergie L, Venara A, Duchalais E, Frampas E, Lehur PA. Internal rectal prolapse: Definition, assessment and management in 2016. J Visc Surg. 2017 Feb;154(1):21-28. doi: 10.1016/j.jviscsurg.2016.10.004. Epub 2016 Nov 16.

  PMID: 27865742 BACKGROUND

• Kluivers KB, Hendriks JC, Shek C, Dietz HP. Pelvic organ prolapse symptoms in relation to POPQ, ordinal stages and ultrasound prolapse assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1299-302. doi: 10.1007/s00192-008-0634-7. Epub 2008 May 9.

  PMID: 18465076 BACKGROUND

• Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. doi: 10.1007/BF02056950.

  PMID: 8646957 BACKGROUND

• Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.

  PMID: 9862829 BACKGROUND

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.

  PMID: 21344495 BACKGROUND

• Sileri P, Franceschilli L, de Luca E, Lazzaro S, Angelucci GP, Fiaschetti V, Pasecenic C, Gaspari AL. Laparoscopic ventral rectopexy for internal rectal prolapse using biological mesh: postoperative and short-term functional results. J Gastrointest Surg. 2012 Mar;16(3):622-8. doi: 10.1007/s11605-011-1793-2. Epub 2012 Jan 7.

  PMID: 22228202 BACKGROUND

• Jayne DG, Schwandner O, Stuto A. Stapled transanal rectal resection for obstructed defecation syndrome: one-year results of the European STARR Registry. Dis Colon Rectum. 2009 Jul;52(7):1205-12; discussion 1212-4. doi: 10.1007/DCR.0b013e3181a9120f.

  PMID: 19571694 BACKGROUND

MeSH Terms

Conditions

Rectal Prolapse; Rectocele

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia

Study Officials

• Simona Ascanelli

  Surgical Department University Hospital Ferrara Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This randomized controlled trial is designed to compare the outcome of patients with obstructed defecation syndrome (ODS) and rectal prolapse undergoing transanal prolassectomy surgery with mechanical stapler (STARR: stapled transanal rectal resection) versus laparoscopic ventral rectopexy (LVR) surgery, with the aim of evaluating the most appropriate surgical choice. Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR). Randomization will be performed by a randomized list. The assignment sequence will be generated from a random numerical series generated through a computerized list. Randomization will be in blocks of 4. Group assignments will be unknown to those responsible for data collection and those who will be responsible for statistical analysis and clinical evaluation of patients.

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: May 19, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)