Inguinal Hernia Management: Watchful Waiting vs. Tension-Free Open Repair
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 1999 |
| End Date: | December 2004 |
Purpose: To determine if observation (watchful waiting is a safe alternative to routine
repair of asymptomatic inguinal hernias in adult males.
Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at
diagnosis to prevent the life threatening complications of bowel obstruction or incarceration
with strangulation and that operation becomes more difficult the longer a hernia is left
un-repaired.
repair of asymptomatic inguinal hernias in adult males.
Scope: Traditionally surgeons are taught that all inguinal hernias should be repaired at
diagnosis to prevent the life threatening complications of bowel obstruction or incarceration
with strangulation and that operation becomes more difficult the longer a hernia is left
un-repaired.
Screening of potential patients for the trial was conducted on all patients presenting to the
surgeon's office with a possible hernia. Unless unequivocal contraindications were present,
patients were scheduled to see the participating surgeon to confirm that they were candidates
for the study. Informed consent for participation in the trial and for randomization was then
obtained. Consent and patient-centered data collection documents were translated into Spanish
and French. After the patient provided informed consent and all inclusion criteria were
satisfied, the Study Coordinator telephoned the center where the staff confirmed eligibility.
The patient was then randomly assigned to either operation or watchful waiting with the
randomization stratified by: participating site, whether the hernia is primary or recurrent,
and bilateral or unilateral hernia. At the time of screening, an anonymous list was
maintained of patients who were not enrolled; reasons for ineligibility or non enrollment
were recorded in addition to patient age and categories of co-morbidities, but no names or
personal identification items were recorded. These data were used to determine recruitment
percentage and whether important differences exist between enrolled and non enrolled
patients.
The procedure described by Lichtenstein was the control operation. A videotape by Amid,
presented at the 1998 Clinical Congress of the American College of Surgeons, was used as the
standard for the Lichtenstein operation. The PIs from each institution reviewed the video at
an investigators' meeting before patient recruitment began and details of the procedure were
agreed upon; all surgeons participating in the trial were willing to follow the procedure as
described. Local anesthesia was recommended but not required.
Several important technical features of the operation were adhered to strictly. The
prosthesis had to be a minimum of 15 cm in width and 7.5 cm high and overlap the pubic
tubercle onto the anterior rectus sheath. A running, non absorbable monofilament suture was
used to secure the inferior border of the prosthesis beginning on the anterior rectus sheath
at least 2 cm medial to the pubic tubercle. The suture was continued laterally on either side
of the pubic tubercle and then along the shelving edge of the inguinal ligament to the
internal ring. Interrupted sutures were used only if it was necessary to incorporate Cooper's
ligament into the repair because of extensive destruction of the inguinal floor or a femoral
hernia. A slit in the lateral end of the mesh was cut to produce a narrow (1/3-width) tail
below and a wider (2/3-width) tail above. The spermatic cord was positioned between the two
tails. The inferior surface of the wider tail was sutured to the inferior surface of the
narrow one and the shelving edge of the inguinal ligament, thereby creating a shutter valve
that acts as a snug-fitting internal ring. This step is considered particularly important to
prevent an indirect recurrence. Simple linear reapproximation was not permitted. The tails
could be trimmed but a minimum of 6 cm lateral to the internal ring was required. Written
postoperative instructions were provided to each patient.
Watchful waiting patients were taught about dangerous hernia symptoms and written
instructions and explanations were provided. Subjects were told to contact their physician if
problems developed. They were seen in person at 6 months, and yearly after enrollment.
Follow-up: Watchful waiting patients were given written instructions to watch for hernia
symptoms and contact their physician if problems developed. Patients were examined at 6
months and yearly after enrollment.
surgeon's office with a possible hernia. Unless unequivocal contraindications were present,
patients were scheduled to see the participating surgeon to confirm that they were candidates
for the study. Informed consent for participation in the trial and for randomization was then
obtained. Consent and patient-centered data collection documents were translated into Spanish
and French. After the patient provided informed consent and all inclusion criteria were
satisfied, the Study Coordinator telephoned the center where the staff confirmed eligibility.
The patient was then randomly assigned to either operation or watchful waiting with the
randomization stratified by: participating site, whether the hernia is primary or recurrent,
and bilateral or unilateral hernia. At the time of screening, an anonymous list was
maintained of patients who were not enrolled; reasons for ineligibility or non enrollment
were recorded in addition to patient age and categories of co-morbidities, but no names or
personal identification items were recorded. These data were used to determine recruitment
percentage and whether important differences exist between enrolled and non enrolled
patients.
The procedure described by Lichtenstein was the control operation. A videotape by Amid,
presented at the 1998 Clinical Congress of the American College of Surgeons, was used as the
standard for the Lichtenstein operation. The PIs from each institution reviewed the video at
an investigators' meeting before patient recruitment began and details of the procedure were
agreed upon; all surgeons participating in the trial were willing to follow the procedure as
described. Local anesthesia was recommended but not required.
Several important technical features of the operation were adhered to strictly. The
prosthesis had to be a minimum of 15 cm in width and 7.5 cm high and overlap the pubic
tubercle onto the anterior rectus sheath. A running, non absorbable monofilament suture was
used to secure the inferior border of the prosthesis beginning on the anterior rectus sheath
at least 2 cm medial to the pubic tubercle. The suture was continued laterally on either side
of the pubic tubercle and then along the shelving edge of the inguinal ligament to the
internal ring. Interrupted sutures were used only if it was necessary to incorporate Cooper's
ligament into the repair because of extensive destruction of the inguinal floor or a femoral
hernia. A slit in the lateral end of the mesh was cut to produce a narrow (1/3-width) tail
below and a wider (2/3-width) tail above. The spermatic cord was positioned between the two
tails. The inferior surface of the wider tail was sutured to the inferior surface of the
narrow one and the shelving edge of the inguinal ligament, thereby creating a shutter valve
that acts as a snug-fitting internal ring. This step is considered particularly important to
prevent an indirect recurrence. Simple linear reapproximation was not permitted. The tails
could be trimmed but a minimum of 6 cm lateral to the internal ring was required. Written
postoperative instructions were provided to each patient.
Watchful waiting patients were taught about dangerous hernia symptoms and written
instructions and explanations were provided. Subjects were told to contact their physician if
problems developed. They were seen in person at 6 months, and yearly after enrollment.
Follow-up: Watchful waiting patients were given written instructions to watch for hernia
symptoms and contact their physician if problems developed. Patients were examined at 6
months and yearly after enrollment.
Inclusion Criteria:
- 18 years of age or older (19 years in Nebraska)
- Male
- Diagnosis of inguinal hernia (patients with bilateral and recurrent hernias are
eligible)
- Inguinal hernia that is either completely asymptomatic or minimally symptomatic (does
not interfere with normal activities
- Informed consent for randomization
Exclusion Criteria:
- A hernia that could not detected on physical examination
- American Society of Anesthesia (ASA) Class IV or V
- Evidence was present of an acute hernia complication such as bowel obstruction,
strangulation, peritonitis, or perforation
- Local or systemic infection
- Presence of pain and discomfort associated with the hernia that limits usual
activities
- A history of recent (within six weeks of visit) onset of difficulty in reducing a
hernia that was previously easily reduced
- Participation in another clinical trial
- Female
We found this trial at
1
site
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
Click here to add this to my saved trials
