Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Ventral Hernia Repair

• Safety and Efficacy as measured by pain and temperature log post-op [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  Patient will be given a 7-day pain and temperature log on which they will record pain/temperature for 7 days post-op.
• Safety and efficacy as measured by # of adverse events. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

This study is looking at the safety and effectiveness of Trans-vaginal ventral or umbilical hernia repair versus the standard laparoscopic repair that is currently being done.

A pilot study looking at a novel surgical approach for a commonly performed laparoscopic surgery; umbilical herniorrhaphy or incisional herniorrhaphy (here in to be defined as ventral herniorrhaphy).

The purpose of the study is to determine the safety and efficacy of the transvaginal approach to an operation, in which the surgeon creates an opening in the vagina and inserts an endoscope into the peritoneal cavity. All instruments and devices in the study are FDA approved for the specific tasks for which they are utilized.

There will be one group in this pilot, with 10 subjects in the group.

Subjects will be female between the ages of 18-64 who present to the general surgery clinic and are subsequently diagnosed with a ventral hernia. Following diagnosis, investigators will be contacted by the surgical consult team to determine if a patient meets criteria for the study. If the patient satisfies the listed criteria then researchers will present study information and offer participation.

Inclusion criteria for NOTES Ventral Herniorrhaphy

1. Females between the ages of 18-64
2. Umbilical or Incisional hernia greater than 2 cm in size

Exclusion criteria for NOTES Ventral Herniorrhaphy

1. Pregnant women (need to have negative icon in ER)
2. Patients with defects measuring greater than 10 cm in size
3. Patients with complex hernias requiring fascial mobilization for closure
4. Morbidly obese patients (BMI >45)
5. Patients who are taking immunosuppressive medications or are immunocompromised
6. Patients with evidence of an abdominal abscess or mass
7. Patients who present with a clinical diagnosis of sepsis or peritonitis
8. Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery or with prior pelvic surgery will be included.
9. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
10. Previous trauma to the perineal area
11. Patients on blood thinners or aspirin or abnormal blood coagulation tests

• Umbilical Hernia
• Ventral Hernia

Inclusion criteria for NOTES Ventral Herniorrhaphy

1. Females between the ages of 18-64
2. Umbilical or Incisional hernia greater than 2 cm in size

Exclusion criteria for NOTES Ventral Herniorrhaphy

1. Pregnant women (need to have negative icon in ER)
2. Patients with defects measuring greater than 10 cm in size
3. Patients with complex hernias requiring fascial mobilization for closure
4. Morbidly obese patients (BMI >45)
5. Patients who are taking immunosuppressive medications or are immunocompromised
6. Patients with evidence of an abdominal abscess or mass
7. Patients who present with a clinical diagnosis of sepsis or peritonitis
8. Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery or with prior pelvic surgery will be included.
9. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
10. Previous trauma to the perineal area
11. Patients on blood thinners or aspirin or abnormal blood coagulation tests