Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

Rectal Cancer Clinical Trial

— NEAPE  

Official title:

Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01347697
• Other study ID #: NEAPE-2010-335-31M
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2011
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are:

• a technique using a gluteus maximus myocutaneous flap or

• a technique using an acellular porcine collagen implant (biological mesh)

The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap.

The study is interventional, randomized and by definition a comparative effectiveness research project.

Description:

Extended abdominoperineal excision (EAPE) of the rectum is the potentially curative operation for rectal carcinomas too low for primary anastomosis, especially if the levator and sphincter musculature is infiltrated. This enlarged operation, when the levator musculature is excised en bloc with the rectum, creates a large defect. Primary closure is often not possible, and reconstruction with prosthetic material or a myocutaneous flap is necessary to avoid a perineal hernia. Implantation of a collagen sheet (biological mesh) has shown preliminary good results and on the other hand, the use of a gluteus myocutaneous flap is routine in many clinics. There is a lack of scientific evidence to prove which method is better for the reconstruction of the lesser pelvic floor.

The current study aims to compare the two reconstruction techniques.

Centres that treat locally advanced rectal cancers with the extended abdominoperineal excision of rectum (EAPE)[Holm et al 2007] can participate provided that:

1. the operative technique is standardized according to the study protocol

2. the centre/unit has resources for examinations of participants by a physiotherapist or a nurse

3. the centre/unit has one investigator in charge of the study locally

4. the centre/unit has an operative volume that enables at least 6 patients to be included/randomised during the anticipated three year study phase for inclusions

Centres that do not operate the rectal cancers included in this study can participate by arranging the preoperative examination and physical tests as well as follow-up of patients that are referred to other centres for the operation. In these cases the operating centre cares for the randomisation, operation and start of postoperative rehabilitation while the study follow-up and final rehabilitation can be completed at the patients' primary referral hospital. The primary referral hospital needs a site investigator in charge of study patients just like centres that do the operations.

Patients with primary or recurrent cancers of rectal origin can be included but individual patients can be included only once. Concomitant therapies are allowed and preoperative or postoperative radiation therapy and/or chemotherapy may be given or not according to local multidisciplinary team (MDT) decisions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional.

Exclusion Criteria:

• Age less than 18 years

• Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction

• Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option

• Expected survival less than one year at operation

• Patient do not sign informed consent document

Related Conditions & MeSH terms

• Defect of Floor of Lesser Pelvis
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Reconstruction with an acellular porcine dermal collagen implant (biological mesh)
Reconstruction of floor of lesser pelvis with an acellular porcine dermal collagen implant (biological mesh) after extended excision of rectum including levator muscles in advanced low rectal cancer.
• Reconstruction with a gluteus maximus myocutaneous flap
Reconstruction of floor of lesser pelvis with an gluteus maximus myocutaneous flap after extended excision of rectum including levator muscles in advanced low rectal cancer.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu
Sweden	Sunderby County Hospital	Luleå
Sweden	Skåne Universtiy Hospital	Malmö
Sweden	Östersund Hospital	Östersund
Sweden	Karolinska University Hospital, Solna	Stockholm
Sweden	Umeå University Hospital, Department of Surgical and Perioperative Sciences	Umeå
Sweden	Uppsala University Hospital	Uppsala
Sweden	Västmanlands Sjukhus Västerås	Västerås

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	The Swedish Society of Medicine, Västerbotten County Council, Sweden

Countries where clinical trial is conducted

Finland,  Sweden, 

References & Publications (2)

Haapamaki MM, Pihlgren V, Lundberg O, Sandzen B, Rutegard J. Physical performance and quality of life after extended abdominoperineal excision of rectum and reconstruction of the pelvic floor with gluteus maximus flap. Dis Colon Rectum. 2011 Jan;54(1):101-6. doi: 10.1007/DCR.0b013e3181fce26e. — View Citation

Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance in Timed-Stands Test	Timed-Stands test is a combined measure of physical performance depending on at least muscle strength, balance, tenderness of gluteal skin and muscles and co-ordination of motion.	6 months after surgery
Secondary	Change in physical performance	Change in Timed-Stands Test performance	3, 6 and 12 months after surgery compared with preoperative results
Secondary	Primary wound healing assessed with the Southampton Wound Assessment Scale	The Southampton Wound Assessment Scale is a validated measure of wound healing after surgery.	3 months from operation
Secondary	Complications according to classification by Dindo-Clavien	The Dindo-Clavien classification of surgical complications is a validated instrument.	3, 6 and 12 months after surgery
Secondary	Proportion of persistent perineal sinus or fistula	Proportion of patients with the wound healing defect of all patients in the particular study arm	3, 6 and 12 months after surgery
Secondary	Ability to sit	Ability to sit is graded with a scale in three degrees.	3, 6 and 12 months after surgery
Secondary	Change of pain and discomfort in gluteal region measured with VAS	A standard visual analogue scale (VAS) from 0-100 mm is used.	3, 6 and 12 months after surgery compared to preoperative
Secondary	Pain and discomfort in gluteal region, spot measures with VAS	A standard visual analogue scale (VAS) from 0-100 mm is used.	3, 6 and 12 months after surgery
Secondary	Change of quality of life measured with EQ-5D and EORTC forms C30 and CR29	EQ-5D and EORTC are validated quality of life instruments	3, 6 and 12 months after surgery compared to preoperative
Secondary	Quality of life spot measures	Quality of life at specified time points	3, 6 and 12 months after surgery
Secondary	Length of hospital stay	Length of index hospital stay in days.	Six months after surgery
Secondary	Costs of surgical treatment	Hospital expenses converted to US$	12 months after surgery
Secondary	Quality-adjusted life years (QALYs gained)	Quality adjusted life year (QALY) is calculated using an quality of life utility index at repeated time points. The utility index is adjusted for the relevant background population.	12 months after surgery
Secondary	Local recurrence	Local recurrence of rectal cancer detected by clinical or radiological investigation	Five years after surgery