Trial Outcomes & Findings for Intraperitoneal Mesh-Implementation After Laparotomy (NCT NCT01003067)

NCT ID: NCT01003067

Last Updated: 2019-08-15

Results Overview

Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.

• Recruitment status: UNKNOWN
• Study phase: NA
• Target enrollment: 267 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-08-15

Participant Flow

Participant milestones

Measure	No Mesh conventional abdominal closure with a suture	Mesh Implementation Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
Overall Study STARTED	136	131
Overall Study COMPLETED	103	107
Overall Study NOT COMPLETED	33	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraperitoneal Mesh-Implementation After Laparotomy

Baseline characteristics by cohort

Measure	No Mesh n=136 Participants The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath).	Mesh Implementation n=131 Participants Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.	Total n=267 Participants Total of all reporting groups
Age, Customized	65.1 years STANDARD_DEVIATION 2 • n=5 Participants	64.1 years STANDARD_DEVIATION 2.3 • n=7 Participants	64.5 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	71 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	60 Participants n=7 Participants	116 Participants n=5 Participants
Region of Enrollment Switzerland	136 participants n=5 Participants	131 participants n=7 Participants	267 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.

Outcome measures

Measure	No Mesh n=103 Participants conventional abdominal closure with a suture	Mesh Implementation n=107 Participants Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy	40 participants	18 participants

SECONDARY outcome

Timeframe: 5 Years

Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.

Outcome measures

Outcome data not reported

Adverse Events

No Mesh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Mesh Implementation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	No Mesh n=136 participants at risk conventional abdominal closure with a suture	Mesh Implementation n=131 participants at risk Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
Gastrointestinal disorders Bowel Fistulation	0.00% 0/136	1.5% 2/131 • Number of events 2

Additional Information

Prof. Christoph A. Maurer

Hirslanden Bern

Phone: +41 31 335 33 33

Email: christoph.maurer@hin.ch

Results disclosure agreements

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