Clinical Trial Conduct on the Surgery. Types of surgery & Its Important. Also Which is Best Clinical Trial To conduct on the Surgery. How To Manage the sub in clinical trial.

1. Clinical Trials in Surgery
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1. Objectives Of Surgical Trial
2. Types of surgical Trial Procedures
3. Management of Surgical Trials
4. Designing Surgical trials
5. Factors to Control Surgical Trial
6. Follow up
7. Ethics committees/IRB Review
8. Types of Randomization & Blinding of Surgical trial
9. Ethics in Surgical trial

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Surgery Definition :- Surgery is the specialty of medicine
that treat’s diseases and disorder’s by cutting, removing or
changing the body with operative procedure that open’s
the body for therapy.

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1. To treat and cure an acute illness… (Breaking a bone, burn)
2. To treat disease that is otherwise fatal and thus prolong life.
3. To treat and cure a chronic illness. (e.g. Heart Diseases )
4. To palliate a slowly progressing disease. ( e.g. Cholesteatoma )
5. To palliate a rapidly progressing diseases.

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There are 8 types of surgical trial procedure
1. Evaluation of medicines or anesthetic agents used during surgical
procedures.(e.g. Neuromuscular blocking agents)
2. Evolution of the diseases treated either by surgery or medicines.
(e.g. Angina, peptic ulcers)
3. Evolution of a disease (e.g. Cancer) treated either by surgery or non
medicine modalities. (e.g. Hyperthermia, radiation)

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4. Comparison of two or more surgical procedures. (e.g. new versus
old method, modified versus original method)
5. Evolution of one surgical procedure (usually a novel technique)
compared with historical controls.
6. Comparison of Surgical procedure performed with and without
medical (or other) adjunct therapy.

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7. Evolution of equipment used in surgery (e.g. Cauterizing machine,
Stereotaxic device) or medical devices (e.g. prosthetic heart valves), either
used or implemented during surgical procedures.
8. Evaluation of surgical materials (e.g. adhesives, suture materials, drapes,
pins, staples) used during surgery.

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The management of well-designed surgical trials is similar to the
management of well-designed medical trials.
Monitoring are the most important part in the surgical trials, monitoring
may be performed by designated surgeon who supervises, evaluates, or
otherwise oversees surgical activities at one or multiple trial sites.

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Team of surgeons or non surgeons who review and oversee the quality and
consistency of the surgical trial.
Surgery is conducted by the surgeons and surgeons should be patient
oriented rather than surgical oriented.
Surgeons chosen for trials should be well-trained physicians who are both
experienced and interested in pre- and postoperative care.

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It insures a
greater degree of
consistency if
one or more non
surgeons take
care of all
patients in a trial
Routine
postoperative
clinical care is
usually allied
with internal
medicine.
Minimize any influence
of investigator
enthusiasm on results,
especially if the
internal medicine
physicians are blind to
patient treatment
If the surgeons chosen, however, are less interested in pre- and post operative
care than performing the surgery it may be relevant to appoint the specialist in inter
medicine to manage (or monitor) patient care. The potential advantages of this
approach are several

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Basic considerations.
Identifying end points and parameters to measure.
Preoperative considerations.
Operative considerations.
Postoperative considerations.
Short term outcome.
Long term outcome.
Training and Technique of Personnel.

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Basic considerations
1. Consider including a placebo or sham operation in the trial.
2. Determine the nature of the control group. (e.g. Historical control, placebo
etc)
3. Consider whether multiple subsets of patient are to be included (e.g.
Cancer patient with different stages of one type of cancer)

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4. Consider weather it is possible to have the patient evaluated independently,
especially if the surgeon and patients will not be blinded to the trial
treatment.
5. Monitor the surgeon’s technique by a head surgeon or equality control
monitoring group.

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Identifying end points and parameters to measure.
A. During surgery
1. Technical ease or difficulty of surgery.
2. Duration of surgery
3. Number of Expertise of staff required to assist during surgery.

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B. After Surgery
1. Morbidity and/ or mortality rates.
2. length of hospital stay.
3.Quality of life at predetermined time points.
4. Cosmetic appearance before and after surgery.

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Preoperative considerations
1. Describe acceptable preoperative care.(e.g. specific pre-operative
medicines, doses, time of administration relative to surgery)
2. Determine Whether the procedures for obtaining informed consent
should be standardized.
3. Determine whether the contact between surgeons and patients
should be limited or avoided in single blind study

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4. Determine whether the surgeon’s level of enthusiasm should be
controlled or measured.
5. Determine whether to alter dosages of medicines patients maybe
taking.
6. Specify patient diet.

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Operative considerations.
1. Specify which anesthetic(s), neuromuscular blocking agents & other
medicines patients receive during the operation.
2. Specify types of dosing of neuromuscular blocking agents
3. Specify the calibration & use of the instrumentation and equipment.

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4. Specify the relevant synthetic & biological materials to be used in
the operation.
5. Specify the pathological and/or X-ray or other examinations to be
conducted during the operation.

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Sort term outcome.
1. Amount of blood loss during surgery.
2. Number of patient failures.
3. Degree of improvement observed and measured.
4. Rate of complication during and after surgery
5. Rate of mortality and reasons for death.

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Long term outcome.
1. Length of follow.
2. Number of patients lost to follow-up.
3. Risk of mortality.
4. Estimate of survival time.
5. Degree of improvement.

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Training and Technique of Personnel
1. Specific qualifications may be indicated for surgeons who are actually
perform the surgery in trial.
2. Specified the required skills for the rest of the surgical team.
3. Specify whether a single surgeon must perform all operations or
whether a group of surgeons may operate and have their results
combined.

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4. Specify the required training in the techniques to be evaluated.
5. Determine whether to measure the skills of the surgeon for each type of
surgery included in a trial.

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Pre surgical, Surgical, and Postsurgical procedures must be identified
in a protocol to help ensure uniformity between surgical procedure and
also to ensure uniformity of care given to different patients.
 e.g. Pre surgical issue is that elemental diet, antimicrobial agents etc.

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e.g. Number of lymph nodes biopsied during surgery. This number should be
identified in the protocol and associated with the level or stages of patient's
disease.
A post surgery issue would involve identifying the technique of stimulating
respiration that is to be used, plus the frequency and other detail we use.

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Some surgical trials measure parameters of improvement post surgery
prior to patient’s discharge & do not require follow up visits.
Follow up period is determined prior to the surgery.

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Length of follow up, may be compromised by a patient’s
1.Lack of corporation.
2.Moving to a new location.
3.Death
4. Loss of follow up for other reasons.

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It is not firmly established which modifications of surgical
procedures require ethics committee/IRB approval.
A possible guideline is that any modification that places patient at
an increased risk during and after surgery should be submit ethics
committee/IRB.

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At a certain point in developing minor modifications of known
method the surgeon should formally initiate a controlled trial that will
not depend upon historical data to evaluate the surgery.
It is understood this is suggestion is not always realistic or possible.

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One alternative to a completely randomized approach is to assign
different surgeries to the surgeons who perform them best and to
randomize patient to different group and therefore different surgeons.
An other alternative is to alternate patient assignment or to assign every
third or forth patient to the standard surgical procedure group
Surgery would be performed by surgeon(s) A. An independent surgeon. &
B. who is blind to patient randomization could be used to evaluate
patients.

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 If the two surgeries could not be blinded for an independent surgeon, then
the independent surgeon could patients and code or describe surgery results on
preprinted forms. These forms could then be evaluated by yet a different
surgeons who was blind to patient treatment.

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