ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12613000606785

Ethics application status

Approved

Date submitted

20/05/2013

Date registered

28/05/2013

Date last updated

7/05/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Pelvic organ prolapse suspension and stapled transanal rectal resection in treatment of obstructing defecation

Scientific title

Pelvic organ prolapse suspension using ventral rectopexy versus stapled transanal rectal resection in treatment of obstructing defecation

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

perineal descent syndrome

Obstructed defecation due to rectocele or Intussusception

Condition category

Condition code

Surgery

Surgical techniques

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Laparoscopic pelvic organ prolapse suspension by prolene mesh fixed to the anterior wall of rectum in one group of patients. Procedure duration approximately 120 minutes. The mesh will remain in situ forever.
A second new intervention group is added which receive stapled transanal rectal resection using Mini Contour stapler .

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Control group is having stapled transanal rectal resection using Mini Contour stapler. .

Control group

Active

Outcomes

Primary outcome [1]

correction of the obstructed defecation symptoms such as sense of incomplete evacuation or difficult evaculation using modified obstructed-defecation syndrome questionnaire (MODS)

Timepoint [1]

6 months

Primary outcome [2]

correction of the fecal incontinence symptoms using wexner incontinence score

Timepoint [2]

6 months

Secondary outcome [1]

quality of life score using SF-36 Quality of Life Questionnaire

Timepoint [1]

6 months

Eligibility

Key inclusion criteria

elderly males or females
Perineal descent
symptoms of obstrucred defecation and/or fecal incontinence

Minimum age

70 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

no exclusions

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/06/2013

Actual

1/06/2013

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Alexandria

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Alexandria

Address [1]

faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321

Country [1]

Egypt

Primary sponsor type

University

Name

University of Alexandria

Address

faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321

Country

Egypt

Secondary sponsor category [1]

Hospital

Name [1]

Gamal abd el Nasser Hospital

Address [1]

El Horria avenue- Ibrahimia- Alexandria, Egypt 21333

Country [1]

Egypt

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Alexandria ethics committee

Ethics committee address [1]

faculty of medicine- Champlion avenue- Azarita- Alexandria- Egypt 21321

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

28/04/2013

Approval date [1]

18/05/2013

Ethics approval number [1]

Summary

Brief summary

In the normal individual the anorectal angle is a factor in maintaining faecal continence. If intra-abdominal pressure is transmitted to the anterior rectal wall, for example during coughing or sneezing, mucosa will be forced onto the upper part of the anal canal to form a flap-valve.
In patients with the descending perineum syndrome, the anorectal angle is disrupted because it lies at a lower level than normal and the patient is complaining of feeling of incomplete evacuation and straining that lead to rectorectal intussusception and/ or  rectocele
Correction of rectorectal intussusception and/ or  rectocele can be done by stapled transanal rectal resection or abdominally by pelvic organ suspension using  ventral rectopexy.

Pelvic organ prolapsed suspension using ventral rectopexy and stapled transanal rectal resection can solve the anatomical problem of obstructed defecation, however no data which would have better results in multiparous females .
Purpose of the study is to compare the outcome of laparoscopic ventral rectopexy versus stapled transanal rectal resection in obstructed defecation in elderly. Our hypothesis is that Laparoscopic ventral rectopexy will have better results as in these patients there is usually weakness of pelvic floor which is not supported in case of stapled transanal rectal resection
Patients and Methods:
80 patients with descending perineal syndrome and obstructed defecation above 70 years of age will be treated by laparoscopic ventral mesh rectopexy or stapled transanal rectal resection by random choice ( two equal groups)

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Khaled Madbouly

Address

faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321

Country

Egypt

Phone

+2034802375

Fax

[email protected]

Contact person for public queries

Name

Khaled Madbouly

Address

faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321

Country

Egypt

Phone

+2034802375

Fax

[email protected]

Contact person for scientific queries

Name

Khaled Madbouly

Address

faculty of medicine- University of Alexandria-Champlion avenue- Azarita- Alexandria- Egypt 21321

Country

Egypt

Phone

+2034802375

Fax

+2034802375

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Laparoscopic Ventral Rectopexy Versus Stapled Transanal Rectal Resection for Treatment of Obstructed Defecation in the Elderly: Long-term Results of a Prospective Randomized Study.	2019	https://dx.doi.org/10.1097/DCR.0000000000001256

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically