BARIATRIC SURGERY THE LEARNING CURVE
David Anaise MD
1001 W San Martin Dr.
Tucson AZ 85704
520-628-7777
Fax 520-844-1452
Gastro-jejunostomy Jejuno-Jejunostomy
( Schauer www.laparoscopy.com)
The Learning Curve
Laparoscopic Roux-en-Y gastric bypass ( RYLGB) is a very complex operation. It
is associated with long and steep learning curve as reflected in a high number
of major complications among the surgeon’s first 70-100 patients
Papasavas et al ( Surgical endoscopy 2003, 17 610
) reported the results of 246 consecutive morbidly obese patients, who underwent
RYLGB. 62 patient's or 25%,of the patients , developed 64 complication, 34
patients required surgical intervention. Gastrojejunostomy stricture was the
most common complication in 9% and followed by intestinal obstruction ,7%, and
gastrointestinal bleeding in 4%. There were three deaths, two of them attributed
to anastomotic leak. They noted that the operation has a steep learning curve
and certain complications notably internal hernias that were infrequently found
after open procedure are much more common due to the laparoscopic technique.
Podnos et al, (archive of surgery, volume 138, September 2003, page 957) collected more than 3000 patients by reviewing articles relating to laparoscopic gastric bypass compared to open gastric bypass. Laparoscopic gastric bypass was associated with a decrease in the frequency of iatrogenic splenectomy, wound infection, incisional hernia, and mortality; however, there was an increase in the frequency of early and late bowel obstruction, gastrointestinal hemorrhage, and stenosis in the laparoscopic group. There was also a higher rate of bowel leak after laparoscopy when compared to open. The leak rate appears to be related to the learning curve. A leak rate of 3% was noted in the first 300 laparoscopic procedures with decrease in the leak rate to 1% in the subsequent 200 cases. Bowel obstruction was likewise more common in the laparoscopic group and this relates to the technical element of construction of the jejunojejunostomy
Suter et al,( surgical endoscopy, 2003, 17, page 603) reported the results of
their first 100 patients who underwent Laparoscopic Roux-en-Y Gastric
Bypass (LYRGB) . They observed that their learning curve probably included
between 100 and 150 patients. With increasing experience, the morbidity rate
becomes more acceptable and comparable to that of the open RYGBP. They concluded
that only surgeons with extensive experience in advance laparoscopic, as well as
bariatric surgery should attempt this procedure.
It is not enough that the surgeon is experienced in laparoscopic surgery. Indeed, prior to embarking on the laparoscopic gastric bypass, Sutter et al have performed 600 laparoscopic procedures and developed specific expertise in laparoscopic upper abdominal procedures. Twenty two patients or 20% of the patients developed a total of 25 postoperative complications, one patient died and seven developed leak at the distal gastric suture line at the gastrojejunostomy and at the jejunojejunostomy, lung embolism occurred in three patients. The complication rate of the first 70 patients was 25% as compared to 2.7% in the last thirty patients done by the surgeons.
On the bright side the learning curve phenomena
shows that when surgeons look for better techniques and revise their operative
methods significant improvement in outcome does occur. Suter describes how his
center in response to observed complications changed their operative techniques.
In order to prevent distal gastric suture line disruption they have switched
from the 4.8 mm staples to a 3.5 mm staples. Later on they have began to
manually suture the distal gastric suture line with a non- absorbable running
suture material and thus avoided the leakage. Suter et al concluded that the
learning curve exceeds a 100 cases and that only surgeon who have extensive
experience in advanced laparoscopic surgery and has mastered intra-corporeal
suturing techniques should embark on this formidable operation. They advised
that surgeons should also have an extensive experience in open bariatric
surgery, commit themselves to the long and time consuming follow up this
patients require and report their results.
Credentialing
The American Society for Bariatric Surgery the American college of surgeons and
other surgical societies have raised concerns about the proliferation of
laparoscopic bariatic surgery performed in community hospitals by surgeons who
are poorly trained and institutions that lack the commitment and resources
needed to care for this complex group of patients.
American Society for Bariatric Surgery Guidelines for Laparoscopic and
Conventional Surgical Treatment of Morbid Obesity addresses peri-operative and
long-term management considerations. The guidelines state:,
"The overall care of patients undergoing bariatric surgery (weight reduction surgery) requires programs to address both perioperative care and long-term care..Patients should have a clear understanding of expected benefits, risk, and long term consequences of surgical treatment. ;Patients require appropriate lifelong follow-up with nutritional counseling and biochemical surveillance. Surgeons need to be aware of the needs of severely obese patients in terms of facilities, supplemental equipment, staff and procedures, and should plan the personal time, specialized staff and/or multi-disciplinary referral system as required. This multi-disciplinary approach includes medical management of co-morbidities, dietary instruction, exercise training, specialized nursing care and psychological assistance as needed. Post-operative management of co-morbidities should be directed by the practitioner familiar with the operation performed and the changes created."
Institutions will qualify for designation as an
American Society for Bariatric Surgery (ASBS) Bariatric Surgery Center of
Excellence when they can document to the Surgical Review Corporation (SRC) that
1) they have the components to perform safe bariatric surgery, and 2) they have
excellent short and long-term outcomes. These indices, therefore, not only
document process, i.e. equipment, supplies, training of surgeons, and the
availability of consultant services, but emphasize results.
The process begins with centers applying first for Provisional Status when they
can demonstrate to the SRC that they have the resources to provide safe and
effective bariatric surgery.:
, Surgical Review Corporation (SRC) is prepared to designate an institution as a
Provisional Center of Excellence if it meets the following conditions as
determined by the BSRC:
1. a. An institutional commitment at the highest levels of the
applicant medical staff and the institution’s administration to excellence in
the care of bariatric surgical patients as documented with an ongoing, regularly
scheduled, in-service education program in bariatric surgery.
b. An institutional commitment that is also demonstrated by employing
credentialing guidelines for bariatric surgery.
This requirement refers to a culture in which the staff is prepared to manage
morbidly obese patients, to manage these individuals with understanding and
compassion, and to appreciate the burdens of the co-morbidities of the disease.
The staff should be aware of the basic concepts of bariatric surgery through
in-service programs. Those directly caring for these patients should be able to
recognize the early signs of the common complications including pulmonary
embolus, anastomotic leak, infection, and bowel obstruction so that these can be
managed promptly.
2. a. The reasonable expectation that the applicant institution will perform at
least 125 bariatric surgical cases per year.
b. The reasonable expectation that each applicant surgeon will have performed at
least 125 total bariatric cases lifetime with at least 50 cases performed in the
preceding 12 month period.
3. The applicant maintains a designated physician Medical Director for bariatric
surgery who participates in the relevant decision-making administrative meetings
of the institution.
The position of Bariatric Surgery Medical Director shall be filled by a
qualified bariatric surgeon who is appointed through the administrative/medical
staff process with hospital minutes documenting his or her participation in the
bariatric program decisions. Regularly scheduled meetings to address the
bariatric program in the institution that involve medical staff, nursing,
administration, central supply, operating room personnel, and the business
office are required.
4. The applicant hospital maintains, within 30 minutes of request, a full
complement on staff of the various consultative services required for the care
of bariatric surgical patients including the immediate availability of an ACLS-qualified
physician on site who can perform patient resuscitations.
The facility must have a full-time staff with experience managing critically
ill, morbidly obese patients with ventilators and invasive hemodynamic
monitoring technologies that can support the management of a critically ill
patient until he or she is sufficiently stable to leave the facility.
5. The applicant maintains a full line of equipment and instruments for the care
of bariatric surgical patients including furniture, wheel chairs, operating room
tables, beds, radiologic capabilities, surgical instruments and other facilities
suitable for morbidly obese patients.
6. The applicant has a bariatric surgeon who spends a significant portion of his
or her efforts in the field of bariatric surgery and who has qualified coverage
and support for patient care.
The surgeon must be certified by the American Board of Surgery (ABS) or the
American Osteopathic Board of Surgery (AOBS), and/or Royal College of Surgeons
of Canada (RCSC). In addition, the surgeon must show evidence of bariatric
surgical expertise in accordance with the guidelines of the American Society of
Bariatric Surgery (ASBS).
Qualified coverage is defined as the coverage required for the full care of a
bariatric patient in the absence of the primary surgeon. The covering surgeon
should be certified by the ABS, AOBS, and/or RCSC, have significant experience
in the care of bariatric surgical patients, and be capable of managing the full
range of complications associated with surgery of the morbidly obese.
In order for the on call surgeon to demonstrate significant experience in
managing bariatric patients and their complications, they must have experience
as the primary surgeon on at least 10 bariatric surgical procedures, or have
assisted on at least 10 cases and have attended the Essentials of Bariatric
Surgery Program of the ASBS. Both the bariatric surgeon and on call surgeon need
to demonstrate activity in the bariatric field by accumulating 25 hours of CME
in bariatric surgery every three years.
7. The applicant utilizes clinical pathways and orders that facilitate the
standardization of perioperative care for the relevant procedure. In addition,
all bariatric surgical procedures are standardized for each surgeon.
It is the surgeon’s responsibility and duty to select which primary operation(s)
he or she will perform and it is the expectation of SRC that the procedure(s),
no matter what the choice, will be done in a standardized manner. Similarly, the
surgeon should determine the details of the planned perioperative care. These
details will be documented so that each member of the surgeon’s team is aware of
the care plan and is prepared to follow the process as outlined by the surgeon.
Unless such a process is followed, outcomes cannot be evaluated.
The clinical pathway protocols, i.e. a sequence of orders and therapies
describing the routine care of the uncomplicated patient, must be available for
review during the site visit.
8. The applicant utilizes designated nurse or physician extenders who are
dedicated to serving bariatric surgical patients and who are involved in
continuing education in the care of bariatric patients.
The hospital should have a subset of nurses who routinely care for the bariatric
patients and receive regular in-service education on their care, preferably
assigned to a designated bariatric floor or wing. There should be a bariatric
coordinator designated to supervise the bariatric program.
The physician’s practice should also have nursing and physician extenders who
provide continuing education and care to the bariatric patients in the practice.
This should be outlined in the practice portfolio if it is a split practice that
still performs significant general surgery.
9. The applicant makes available organized and supervised support groups for all
patients who have undergone bariatric surgery at the institution.
The activities of the support group should be documented including group
locations, meeting times, supervisor, curriculum, and attendance. For example,
such activities as on-line chat rooms, web-based support groups, exercise,
instruction, and clothing sales should be noted.
10. The applicant provides documentation of a program dedicated to a goal of
long-term patient follow-up of at least 75% for bariatric procedures at five
years with a monitoring and tracking system for outcomes, and agreement to
provide annual outcome summaries to SRC in a manner consistent with Health
Insurance Portability and Accountability Act (HIPAA) regulations.
This requirement is based on the observation that a significant number of
patients develop nutritional deficiencies, internal and external hernias, return
of previous emotional disorders, as well as other late complications. There is
no requirement that the surgeon provide the follow-up personally, only that he
or she is aware of the long-term status of the patient. Accordingly, the
follow-up data can be gathered during group sessions, reunions, or through
visits at other physicians' offices. The applicant agrees to enter all patients
who undergo surgery in the group's or individual practice; no patients will be
excluded.