Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06120114 |
| Other study ID # |
2015/1053(REK) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2015 |
| Est. completion date |
October 7, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
University Hospital of North Norway |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Inguinal hernia surgery has undergone significant and extensive transformation, including the
advent of tissue-based repairs and later, tension-free repairs with the acceptance of
prosthetic mesh. However, there is still significant pain associated with the use of mesh, as
well as the risk of potential injury to neurovascular structures. In the pediatric
population, non-mesh laparoscopic high-ligation repair of indirect inguinal hernias is one of
the most common procedures performed. High-ligation of indirect inguinal hernias in the
adolescent population is also effective, with a low recurrence rate and low incidence of
chronic symptoms, but this technique is uncommonly used by adult hernia surgeons due to
concern for recurrence.The purpose of this study is to conduct a pilot trial to examine the
efficacy of high-ligation repair of indirect inguinal hernias in adult patients.
Our hypothesis is that the laparoscopic, non-mesh repair technique is an effective method of
repairing indirect inguinal hernias, with an acceptable recurrence rate and decreased
postoperative pain. This pilot trial will allow the design of a randomized clinical trial
comparing the efficacy of this technique to other standard repair techniques.
Description:
Recruitment:
The participants will be recruited from the Department of Digestive Surgery, University
Hospital North Norway, Tromsø. The patient will be asked to participate in the study after
evaluation by the principal investigator when candidacy has been established. The
investigator or study staff will discuss the study with the patient and the study staff will
participate in reviewing details and questions regarding the study if necessary. For each
subject, written informed consent will be obtained prior to any protocol-related activities.
As part of this procedure, the principal investigator or one of the associates must explain
orally and in writing the nature, duration, and purpose of the study in such a manner that
the subject is aware of the potential risks, inconveniences, or adverse effects that may
occur. Patients should be informed that the subject may withdraw from the study at any time.
Preoperative evaluation:
All patients will undergo our standard pre-operative evaluation and at this visit it will be
determined if the patient is a candidate for this study. At this study visit, the doctor will
ask about past medical and surgical history and any medications the patient is taking and
conduct a physical examination. If the patient qualifies for study participation, the patient
will be asked to join the study. If the patient chooses to participate, the study staff will
collect additional information such as gender, age, height, weight, medical and surgical
history, and information relating to the hernia. Patients will be asked to fill out and
complete 3 quality of life questionnaires (Short Form-36, Activities Assessment and a
Surgical Site Pain Scale) that ask about activities and how the hernia impacts what they can
do.
Study intervention:
On the day that the hernia is repaired, the surgery will be performed in the laparoscopic
manner, without the use of mesh reinforcement material. As part of the study, the surgeon
will collect information about the hernia and surgery, such as the size and length of the
hernia, operative time. A 10 mm incision is made below the umbilicus. A 10 mm trocar and
camera are inserted through the umbilical incision and the abdomen is insufflated to 12 mm
Hg. An extra 5 mm Maryland dissector is inserted through a 5 mm trocar in the lower left
quadrant of the abdominal wall. A small 1 mm incision is made in the inguinal area.
Hydrodissection with 0.25% bupivacaine is carried out to disassociate the peritoneum from the
inguinal canal cord structures. Next, an 19-gauge spinal needle is prepared by threading a
loop of 3-0 Prolene suture into the barrel of the needle. The needle is inserted through the
inguinal incision and pierces the peritoneum to enter the abdominal cavity. No injury to the
cord structures occurs because of the previous hydrodissection technique. The Prolene loop is
threaded through the needle, and the needle is pulled out of the abdominal wall, leaving the
suture loop in place. A second loop of 3-0 Prolene suture is threaded into a new 19-gauge
spinal needle. This second threaded needle is inserted through the same inguinal incision and
pierces through the peritoneum at or near the same point of the first needle. The first
suture loop is lassoed around the needle, before the second suture loop is threaded out of
the needle and into the abdominal cavity. The needle is pulled out, leaving both suture loops
in the abdominal cavity, with the first loop threaded around the second loop. Next, the first
suture loop is pulled out of the abdominal wall, which snares the second loop along with it
and closes the inguinal hernia defect as it pulls through. The Prolene suture is then
exchanged with a braided 2-0 Ethibond (non-absorbable) suture by pulling through the incision
site. This suture is doubly ligated. After desufflation of the abdominal cavity, the fascia
below the umbilicus and the skin incisions are closed with sutures. The operative time is
predicted to be between 20-60 minutes.
Follow-up:
Patients will be given instructions to return to the surgeon's clinic to be examined by their
surgeon at 1 month (+/- 2 weeks), and 1 year (+/- 1 month) following surgery. The patients
will have their abdominal wound evaluated and be examined for general health and hernia
recurrence. They will be asked about any medications they are taking and about any problems
they may have had with their hernia repair. Information about any procedures that may be
performed during this time will be collected. Patients will be asked to complete the same
surveys that they filled out prior to surgery at each of these visits. If at any time
throughout the study a hernia recurrence is suspected clinically, then a physical examination
will be performed to evaluate the repair.
Data confidentiality:
All information collected, such as name or medical record number will be in a
password/firewall protected computer to which only the investigators will have access. All
research data will be recorded and stored in a locked office in the Department of Digestive
Surgery. All Photographs will be stored separately in a locked cabinet and de-identified by a
subject identification number. Only investigators and members of the research team will have
key access.
Data analysis:
Since this is a pilot trial, there is no comparison or control arm in this study. Statistical
tests will be used when appropriate, but otherwise the purpose of this study will be to
report outcomes and feasibility.
Research related injury:
If injury occurs as a result of the involvement in this research, medical treatment will be
given by, or under the auspices of the Dept of Digestive Surgery.
