Abdominal cavity will be closed by a single layer of 2 continuous sutures beginning on the opposite ends of the wound towards the median line and involving peritoneum, transversalis fascia, posterior and anterior layer of rectus abdominis muscle fascia and, in case of incisions beyond the lateral border of rectus abdominis muscle, also the oblique abdominal muscles fascia.

Abdominal cavity will be closed with two separate layers of continuous sutures. The first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia. In case of incisions not exceeding the lateral border of rectus abdominis muscle, the second layer will involve only the anterior layer of the rectus abdominis muscle fascia. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer will include internal oblique abdominal muscle fascia, external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.

Incisional Hernia

Malignancy

Mass closure technique

he first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia closed with 2 continuous sutures beginning at both ends of the wound. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer of the continuous suture will start at the lateral border of rectus abdominis muscle, process laterally to the lateral end of the wound involving internal oblique abdominal muscle fascia. Subsequently, the suture will be led out on the anterior surface of the external oblique abdominal muscle, put through by the created loop in the medial direction and processed medially to close the external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.

Layered closure technique

Department of General, Transplant and Liver Surgery

Risk Factors for Development of Incisional Hernia in Transverse Incisions

Study on the Risk of Incisional Hernia Development Following Transverse Epigastric Incisions in Patients Operated for Malignant Tumors

Development of burst abdomen in the immediate postoperative period (until discharge from hospital) or incisional hernia over a 2-year follow-up period (combined end-point). The follow-up protocol used for the assessment of incisional hernias at discharge from hospital and two control visits at 1 and 2 years postoperatively.

Quality of life assessed in EORTC QLQ-C30 questionnaire

surgical site infections, defined and classified according to the CDC (Centers for Disease Control) recommendations

Complications of grade III or higher according to Clavien-Dindo classification

Duration of postoperative hospitalization in days

Medical University of Warsaw

National Science Centre, Poland

The technique comprising continuous suture and mass closure will be compared to the technique 2 separate layers of continuous sutures.
Patients will be randomly assigned to one of the two techniques of abdominal closure during the operative procedure and after its main part has been completed, just before the beginning of closure of the abdominal cavity. Randomization will be performed in a 1:1 ratio and in blocks of 20 patients.

Neither the patients included in the study nor the investigators assessing the presence of incisional hernia during follow-up visits will be aware of the type of surgical technique used for abdominal closure (double-blinded study). Only the professionals present in the operating room during surgical procedure, including operator, assistants, anesthesiologist, and nurses, will be aware of the type of assigned intervention.

Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.
Alvimopan: Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Alvimopan (Entereg)

Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.
Placebo: Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Suger Pill (Control)

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Time to gastrointestinal recovery will be measured by the following:
Time to first flatus and time to first bowel movement measured twice daily. Toleration of a diet and toleration of oral pain medication defined as ingestion of diet or medications that occurs without vomiting or significant nausea for four hours following ingestion.
GI-2 recovery defined as both toleration of solid food and occurrence of first bowel movement. GI-3 recovery is defined as toleration of solid food and either occurrence of first flatus or occurrence of first bowel movement.
Patients requiring nasogastric tube insertion, requiring reduction or restriction of diet, having episodes of emesis, and/or needing initiation of Total Parenteral Nutrition (TPN) will be recorded. VAS (visual analog pain scale), nausea, and bloating will be recorded by nursing staff at least twice daily. The number of doses of anti-nausea medication administered during the hospitalization will also be recorded.

Length of Time (Hrs/Days) to Gastrointestinal Tract Recovery

Length of stay will be measured in hours from the time that surgery is completed until the hospital discharge order is written (hrs/days).

Length of Hospital Stay

Treatment (study drug) and surgery (complications as a direct result of surgery) related morbidity and re-admission rates will be assessed from the time surgery is completed to 30-days post-operatively. Treatment related morbidity and re-admission rates include: post-operative ileus (POI), indigestion and any event determined by the attending physician to be directly related to treatment (study drug). Surgical complications include: hernia recurrence, infections, and any event determined by the attending physician to be directly related to surgery.

30-day Treatment Related Morbidity and Re-admission Rates

Overall Study

Matthew Goldblatt, MD

Ventral Hernia

Alvimopan

Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Placebo

Froedtert & the Medical College of Wisconsin

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair: A Multi-Center, Randomized, Double-Blind, Trial of Alvimopan and Placebo

incisional hernia/diarrhée

Risk Factors for Development of Incisional Hernia in Transverse Incisions

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

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