The objective is to determine the best surgical strategy for internal and external full thickness rectum prolapse in terms of morbidity, mortality, constipation, fecal continence, recurrence rates and quality-of-life of the treated individuals.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the post-operative morbidity, measured by the number of
hospital re-admissions and surgical reintervention needed.
Secondary outcome
Secondary endpoints are the comparision of pre- and postoperative:
quality-of-life, incontinence (Vaizey-score), constipation (Altomare score),
recurrence (physical exam / defecogram) and urogenital functioning
(questionnaire and micturition diary). Futhermore, length of hospital stay,
mortality, total in-hospital costs and the rate of extra outpatient visits are
compared.
Background summary
A Rectal prolapse (RP), or procidentia, is the descent of the upper rectum, and
can be either internal or through the anus (external), in which an internal
rectal prolapse seems to be the precursor of an external prolapse. RP*s occur
predominantly (80-90%) in women, of wich most after the fifth decade. The most
common symptoms are fecal incontinence and constipation. Operation is the only
definite treatment, and two main catogories can be indentified: perianal
procedures and abdominal procedures. Due to higher recurrence rates in perianal
procedures and better functional outcome in the abdominal procedures, this
latter approach has the preference in patients with low co-morbidity. Nowadays,
a laparoscopic approach has the preference above the laparotomic approach
because of less operation related morbidity. Two frequently applied abdominal
procedures are the laparoscopic ventral rectopexy (mainly in Europe) and
laparoscopic resection rectopexy (mainly in the USA). As there are no
randomised trials comparing these techniques and there are no guidelines for
clinical practice concerning rectal prolapse this study is designed to
determine the best surgical strategy.
Study objective
The objective is to determine the best surgical strategy for internal and
external full thickness rectum prolapse in terms of morbidity, mortality,
constipation, fecal continence, recurrence rates and quality-of-life of the
treated individuals.
Study design
Multicenter randomised clinical trial with an initial follow-up of 2 years and
long-term follow-up up to 10 years.
Intervention
Two standardized surgical intervention techniques are compared. The first is
the laparoscopic resection rectopexy (Frykman-Goldberg procedure, LRR), in
which the rectal prolapse is treated by a resection of the rectum combined with
suture rectopexy fixation of the rectosigmoid at the sacrum. The second is
laparoscopic ventral rectopexy (LVR) in which the rectum is mobilised ventrally
and fixed with a mesh from the sacrum to the ventral rectum.
Study burden and risks
-The potential benefit of participation in this study for this specific group
of patients is the determination of the best treating method for rectum
prolapse.
-The close follow-up regarding objective and subjective outcome of treatment in
the studied subjects is also likely to be beneficial, as wel as additional
research, done at 6 months of follow-up. This additional research will monitor
possible recurrences of the rectal prolapse early.
Burdens:
-For both groups, the general risks of surgery are attached to the operations.
We expect the risk of severe morbidity in the LRR group to be higher, mainly
due to the risk of anastomotic leakage, approximately 10% versus 1% in the LVR
group.
-The filling out of the quality of life questionnaires. The filling out of
these surveys will take approximately 30 minutes of the patient*s time
pre-operative, as well as 30 minutes after six months of follow-up.
Utrechtseweg 160
3818 ES Amersfoort
Nederland
Utrechtseweg 160
3818 ES Amersfoort
Nederland
Listed location countries
Age
Inclusion criteria
-Internal or external full thickness rectal prolapse
Exclusion criteria
-Under 18 years old
-No rectal prolapse but bal or mucosa prolapse
-Rectosigmoid tumor or extensive diverticulitis
-Former rectosigmoid resection or rectal/vaginal prolapse surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29325.100.09 |