Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients

NCT00735605 | Completed DMC

• 1 other identifier: anismus surgical and non
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation. Anismus is a significant cause of chronic constipation. This study came to compare the results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients. Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional constipation were included in this study. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the EAS. All patients had non relaxing puborectalis muscle.. The patients were randomized into three groups. Group I patients received biofeedback therapy, two times per week for about 1 month. Group II patients were injected with BTX- A. Group 111 partial division of puborectalis was done. Follow up was conducted weekly in the first month then monthly for about 1 year.

Conditions

Obstructed Defecation; Anismus; Constipation

Keywords

obstructed defecation; constipation; puborectalis

Outcome Measures

Primary Outcomes (1)

• improvement in bowel habit (regarding the straining severity, anorectal pain,number of weakly bowel movement,sensation of incomplete defecation and need of digitation or enema and using constipation score)

  1 year

Secondary Outcomes (1)

• per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication

  1 year

Study Arms (3)

1:BFD

ACTIVE COMPARATOR

The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip

Other: BFD

2 BTX A

ACTIVE COMPARATOR

Injected with BTX-A in the left lateral position; anesthesia was not required

Other: BTX A

3: PDPR

ACTIVE COMPARATOR

Inner half of puborectalis sling was divided on each side by using a scalpel NO

Procedure: PDPR

Interventions

BFD OTHER

The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip

Also known as: BIOFEEDBACK RETRAINING

1:BFD

PDPR PROCEDURE

A 2-3 cm curved incision is made on either side of the anal canal along its posterolateral aspect, each about 2.5 cm distance from the anal verge Fig(2). After that dissection in ischiorectal fossa was done till reaching the puborectalis sling from outside i.e. extrasphincteric approach . Using a right angle forceps the puborectalis sling is lifted up, guided by the contralateral index finger in the anal canal Fig(3). Nearly the inner half of puborectalis sling was divided on each side by using a scalpel NO. 11 Fig(4). Complete haemostasis was followed by skin closure without drain

Also known as: PARTIAL DIVISION OF PUBORECTALIS

3: PDPR

BTX A OTHER

A vial of Dysport, 500 u, (Dysport, Ipsen, United Kingdom) is dissolved in 2.5 ml isotonic saline Fig(1). A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient

Also known as: BOTILINUM TOXIN

2 BTX A

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients fulfilled Rome II criteria for functional constipation
• All patients were unresponsive to laxatives or enema use

You may not qualify if:

• Pregnant patients
• Patients with sphincteric defect
• Any patient proved to have colonic inertia by colon transit time
• Any patient with previous history of pelvic surgery e.g. mesh rectopexy
• Duhamel operation were excluded

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ayman Elnakeeb

Al Mansurah, Egypt

Location

Related Publications (5)

• Farid M, El Monem HA, Omar W, El Nakeeb A, Fikry A, Youssef T, Yousef M, Ghazy H, Fouda E, El Metwally T, Khafagy W, Ahmed S, El Awady S, Morshed M, El Lithy R. Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients. Int J Colorectal Dis. 2009 Jan;24(1):115-20. doi: 10.1007/s00384-008-0567-0. Epub 2008 Aug 22.

  PMID: 18719924 BACKGROUND

• Farid M, Youssef T, Mahdy T, Omar W, Moneim HA, El Nakeeb A, Youssef M. Comparative study between botulinum toxin injection and partial division of puborectalis for treating anismus. Int J Colorectal Dis. 2009 Mar;24(3):327-34. doi: 10.1007/s00384-008-0609-7. Epub 2008 Nov 29.

  PMID: 19039596 RESULT

• Maria G, Brisinda G, Bentivoglio AR, Cassetta E, Albanese A. Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome. Dis Colon Rectum. 2000 Mar;43(3):376-80. doi: 10.1007/BF02258305.

  PMID: 10733120 RESULT

• Kamm MA, Hawley PR, Lennard-Jones JE. Lateral division of the puborectalis muscle in the management of severe constipation. Br J Surg. 1988 Jul;75(7):661-3. doi: 10.1002/bjs.1800750713.

  PMID: 3416122 RESULT

• Park UC, Choi SK, Piccirillo MF, Verzaro R, Wexner SD. Patterns of anismus and the relation to biofeedback therapy. Dis Colon Rectum. 1996 Jul;39(7):768-73. doi: 10.1007/BF02054442.

  PMID: 8674369 RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ayman elnakeeb, MD

  MANSUORA UNIVERSITY HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: September 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

EG (1)