To determine whether there is any difference in the cosmetic result among women undergoing surgery for gynaecological diseases using two different lower transverse abdominal incisions: the Pfannenstiel incision versus a comparable technique in which…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cosmetic outcome of the operative scar, judged by both an independent observer
and the patient herself.
Secondary outcome
surgical convenience, pain, wound hematoma, wound infection, wound dehiscence.
Background summary
In gynaecological surgery transverse incisions are frequently used.
Notwithstanding its very acceptable cosmetic result, women complain sometimes
about overhanging of the skin (and subcutis) above the scar, probably caused by
the retraction of the scar tissue of the fascia and of the skin in the same
level, with subsequent *belly formation* above the scar.
Study objective
To determine whether there is any difference in the cosmetic result among women
undergoing surgery for gynaecological diseases using two different lower
transverse abdominal incisions: the Pfannenstiel incision versus a comparable
technique in which the fascia incision is put 3-5 centimeters higher than the
level of the skin incision.
Study design
A randomised controlled clinical trial. Both patients and independent observers
are blinded for the used surgical technique.
Intervention
Apply either the classic Pfannenstiel technique when openening the abdominal
cavity (control group) or an alternative technique, described in the paragraph
"Objective of the study" (study group).
Study burden and risks
Patients will not experience any extra discomfort by participating in this
study and, apart from the one extra visit to the outpatient clinic 6 months
after the operation, it will not cost them any extra time.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
All women undergoing a laparotomy for a gynecological condition through a low transversal abdominal incision
Exclusion criteria
- dark skin (because of a higher risk of hypertrophic scar tissue or keloid formation)
- having had an operation through a low transverse abdominal incision before
- pregnancy.
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 | NL19676.058.07 |