Trial Outcomes & Findings for Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM (NCT NCT00673400)

NCT ID: NCT00673400

Last Updated: 2012-10-02

Results Overview

Quality of life is measured by Fecal incontinence quality of life (FIQL) Possible range of score 0 - 4 (Depression/Self perception 4.4) 0 = worst condition * Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 6 months after intervention
• Results posted on: 2012-10-02

Participant Flow

Participant milestones

Measure	Stapled TransAnal Rectal Resection patients were operated by stapled transanal rectal resection
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

Baseline characteristics by cohort

Measure	Stapled TransAnal Rectal Resection n=52 Participants patients were operated by stapled transanal rectal resection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Age Continuous	63.2 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Switzerland	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after intervention

Population: Participating in the FIQL survey was voluntarily. Some patients did not participate at all, some did not answer all questions. Patients answering \>=50% of questions of a domain were counted as participants

Quality of life is measured by Fecal incontinence quality of life (FIQL)

Possible range of score 0 - 4 (Depression/Self perception 4.4)

0 = worst condition

• Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)

Outcome measures

Measure	Before Surgery n=35 Participants outcome measured within one month before surgery	6 Months After Surgery n=41 Participants outcome measured within one month before surgery	3 Months After Surgery outcome measured 3 months after surgery	6 Months After Surgery outcome measured 6 months after surgery
Quality of Life Lifestyle (LS)	3.2 units on a scale Interval 2.4 to 3.6	3.7 units on a scale Interval 2.4 to 4.0	—	—
Quality of Life Coping/behavior (C/P)	2.8 units on a scale Interval 2.1 to 3.6	3.3 units on a scale Interval 2.2 to 4.0	—	—
Quality of Life Depression/self-perception (D/S)	3.3 units on a scale Interval 2.3 to 3.9	3.9 units on a scale Interval 3.1 to 4.1	—	—
Quality of Life Embarrassment (E)	3.3 units on a scale Interval 2.3 to 4.0	4.0 units on a scale Interval 3.7 to 4.0	—	—

SECONDARY outcome

Timeframe: 1 year

Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)

Outcome measures

Measure	Before Surgery n=52 Participants outcome measured within one month before surgery	6 Months After Surgery outcome measured within one month before surgery	3 Months After Surgery outcome measured 3 months after surgery	6 Months After Surgery outcome measured 6 months after surgery
Morbidity overall	6 participants	—	—	—
Morbidity Urinay retention (Dindo IIIa) (within 30 days)	1 participants	—	—	—
Morbidity self limiting rectal bleeding (Dindo I)(6 weeks)	2 participants	—	—	—
Morbidity Pain from residual staple (Dindo IIIa)(6 weeks)	2 participants	—	—	—
Morbidity Perianal venous thrombosis (Dindo IIIa) (5 weeks)	1 participants	—	—	—

SECONDARY outcome

Timeframe: 1 day to 1 year (until release from hospital)

Length of hospital stay (Date of release - Date of admission + 1)

Outcome measures

Measure	Before Surgery n=52 Participants outcome measured within one month before surgery	6 Months After Surgery outcome measured within one month before surgery	3 Months After Surgery outcome measured 3 months after surgery	6 Months After Surgery outcome measured 6 months after surgery
Hospitalization	5 days Interval 2.0 to 29.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: before surgery - 6 weeks - 3 months - 6 months

Score based on the severity of 9 symptoms of bowel movement (physician administered)

(0 - 36, no symptoms = 0)

Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950)

Outcome measures

Measure	Before Surgery n=52 Participants outcome measured within one month before surgery	6 Months After Surgery n=52 Participants outcome measured within one month before surgery	3 Months After Surgery n=46 Participants outcome measured 3 months after surgery	6 Months After Surgery n=25 Participants outcome measured 6 months after surgery
Severity of Symptoms Score	15 units on a scale Interval 13.0 to 17.0	4 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 2.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: before surgery - 6 weeks -3 months - 6 months

Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered)

(0 - 40, no symptoms = 0)

Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1)

Outcome measures

Measure	Before Surgery n=52 Participants outcome measured within one month before surgery	6 Months After Surgery n=52 Participants outcome measured within one month before surgery	3 Months After Surgery n=46 Participants outcome measured 3 months after surgery	6 Months After Surgery n=25 Participants outcome measured 6 months after surgery
Obstructive Defecation Syndrome Score	16 units on a scale Interval 14.0 to 18.0	5 units on a scale Interval 3.0 to 6.0	4 units on a scale Interval 3.0 to 5.0	5 units on a scale Interval 2.0 to 7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Before surgery - 6 months

Quality of life short form 36 version 2(SF36v2) standard form

PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best)

A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10)

Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000.

Outcome measures

Measure	Before Surgery n=35 Participants outcome measured within one month before surgery	6 Months After Surgery n=41 Participants outcome measured within one month before surgery	3 Months After Surgery outcome measured 3 months after surgery	6 Months After Surgery outcome measured 6 months after surgery
SF36 Component Summary Scores Physical component summary (PCS)	51 units on a scale Interval 43.0 to 55.0	52 units on a scale Interval 35.0 to 55.0	—	—
SF36 Component Summary Scores Mental component summary (MCS)	39 units on a scale Interval 33.0 to 51.0	53 units on a scale Interval 40.0 to 58.0	—	—

Adverse Events

Stapled TransAnal Rectal Resection

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Stapled TransAnal Rectal Resection n=52 participants at risk patients were operated by stapled transanal rectal resection
Injury, poisoning and procedural complications persisting pain due to residual staples	3.8% 2/52 • Number of events 2 • 1 year Grading of adverse events according to Accordion/Dindo Scale see also secondary outcome: morbidity (Ann Surg (2004) 240:205)
Blood and lymphatic system disorders thrombosis	1.9% 1/52 • Number of events 1 • 1 year Grading of adverse events according to Accordion/Dindo Scale see also secondary outcome: morbidity (Ann Surg (2004) 240:205)
Renal and urinary disorders urinary retention	1.9% 1/52 • Number of events 1 • 1 year Grading of adverse events according to Accordion/Dindo Scale see also secondary outcome: morbidity (Ann Surg (2004) 240:205)

Additional Information

Ulrich Beutner PhD

Cantonal Hospital St. Gallen, Department of Surgery

Phone: +41 71 494 1111

Email: ulrich.beutner@kssg.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place